Cresilon TRAUMAGEL for EMS 30 mL Syringe, model TG-0001, sterile peel pouch with the prefilled hemostatic gel syringe, Pacific Biomedical
Cresilon TRAUMAGEL for EMS 30 mL Syringe, model TG-0001, sterile peel pouch with the prefilled hemostatic gel syringe, Pacific Biomedical
Cresilon TRAUMAGEL hemostatic gel applied into a simulated 9 mm wound channel, demonstration video, Pacific Biomedical
Cresilon TRAUMAGEL training video: clinical application of the 30 mL hemostatic gel syringe for EMS, Pacific Biomedical

TRAUMAGEL for EMS: 30mL Syringe

SKU: CRE-TG-30-010E-EA

Cresilon

Cresilon TRAUMAGEL (Cresilon model TG-0001, SKU CRE-TG-30-010E-EA) is a sterile, single-use 30 mL prefilled syringe of plant-based hemostatic gel for temporary external use to control moderate to severe bleeding. This product is one syringe, sold as each, and one syringe is one application: the full 30 mL is expelled at the bleeding source. The sealed pouch holds the syringe with its applicator tip and cap, ready to use with no mixing or preparation. Gauze is still packed on top of the gel and palm pressure is held for three minutes, so pair it with gauze and a pressure dressing. Add to cart for the quantity you need; the price shown is per syringe.

ModelTG-0001
Pack Size1 syringe (each)
Fill Volume30 mL
SterilitySterile, single use
IndicationModerate to severe external bleeding
StorageDry, 20 to 25 C (68 to 77 F)

Product Highlights

  • No mixing and no preparation: unscrew the cap, place the applicator tip at the bleeding source, and expel the full 30 mL.
  • The applicator tip carries the gel deep into the wound track, as close to the bleeding source as possible, and gauze goes on top.
  • Stops the flow of blood by adhering to the wound site and forming a mechanical barrier while the body builds its own clot. No thrombin and no other biologics.
  • Plant-based chitosan and sodium alginate polymers, non-animal derived, in a viscous, opaque, tan gel.
  • FDA 510(k) cleared (K240713, August 14, 2024) and made in Brooklyn, New York, by an ISO 13485:2016 certified manufacturer.
  • Removed at the emergency department within 24 hours using saline-soaked gauze and saline lavage.
  • Stores dry at ambient temperature (20 to 25 C), individually pouched, with the lot and expiration date on the label.

Where TRAUMAGEL fits in prehospital hemorrhage control

TRAUMAGEL is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding. FDA cleared it under 510(k) K240713 on August 14, 2024, as a hemostatic wound dressing without thrombin or other biologics (product code QSY), with CELOX Gauze Pro as the predicate.1 Applied directly to the source of bleeding, the gel adheres to the wound site and forms a mechanical barrier that stops the flow of blood and lets the body create a natural clot.2

Per the Instructions for Use: identify the bleeding source and clear as much blood as possible with gauze or suction; unscrew the cap, insert the applicator tip deep into the wound as close to the bleeding source as possible, firmly and quickly expel all contents and withdraw; pack gauze into the wound opening on top of the gel; then apply moderate palm compression, hand over hand, for three minutes or until hemostasis is achieved, without ejecting the underlying gel.3 Additional gauze or a pressure dressing may be applied to maintain pressure, and the time to a stable clot varies with patient factors.4 The gel must be removed within 24 hours; removal is an emergency department procedure using saline-soaked gauze and saline lavage, not a field step.2,3

In a 17-patient EMS case series from Cobb County Fire and Emergency Services (April to August 2025), hemostasis was reached within three minutes and held through transport in 16 of 17 applications; the one failure was a stab wound with an application error, and no immediate complications were reported.5 Published case reports describe hemorrhage control on a complex scalp laceration in an 84-year-old taking clopidogrel after direct pressure and conventional hemostatic measures failed,6 tourniquet removal without rebleeding in three extremity injuries treated by LSU Health New Orleans and East Baton Rouge Parish EMS,7 and tourniquet release with restored distal perfusion during a prolonged evacuation after a partial hand amputation.8 In an independent U.S. Army Institute of Surgical Research porcine femoral artery model, survival with TRAUMAGEL equaled Combat Gauze (71.4 percent each) and trailed XSTAT (85.7 percent) with no difference in overall survival duration among the three, post-treatment blood loss was higher than with XSTAT, and TRAUMAGEL was the fastest to apply and conformed best to the wound.9 In a randomized trial in 18 calves with a carotid arteriotomy, TRAUMAGEL plus direct pressure reached hemostasis in a median of 170 seconds versus 1,134 seconds with direct pressure alone.10

Combat Gauze remains the CoTCCC hemostatic dressing of choice in the May 2026 TCCC guidelines, and TRAUMAGEL is not on that list.11 TRAUMAGEL launched nationwide in January 2025 after a rollout in Boston, New Orleans, Denver and Columbus with regional EMS agencies, fire departments, academic medical centers and Level I trauma centers,12 and as of July 2026 it is in use by more than 150 EMS agencies.13 TRAUMAGEL 2.0 (K253609, cleared December 12, 2025) keeps the same gel and 30 mL fill with updated syringe, cap, plunger and stopper materials,14 and the Next Generation compact syringe announced in September 2026 uses the same gel; the original 30 mL syringe remains available and supported.15 Application follows your agency protocol, medical direction and the Instructions for Use.

Specifications and Compatibility

Specification Detail
Manufacturer Cresilon Inc., Brooklyn, New York, USA (ISO 13485:2016 certified)
Model and part numbers Cresilon model TG-0001 (GUDID);16 SKU CRE-TG-30-010E-EA; Cresilon box catalog numbers TG-30-005 (5 syringes), TG-30-010 (10) and TG-30-050 (50)17
GTIN (primary DI) 00860007891144; manufacturer carton of 5 syringes 0086000789115116
FDA 510(k) K240713, cleared August 14, 2024; product code QSY, hemostatic wound dressing without thrombin or other biologics
Indication Temporary external use for controlling moderate to severe bleeding
Fill volume and pack 30 mL per syringe; one syringe per sterile pouch; sold as each; one syringe is one application
Composition Chitosan [poly(N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel; plant-based polysaccharides, non-animal derived
Appearance Viscous, opaque, tan gel; naturally derived polymers may look darker over time
Sterilization Gamma irradiation, sterility assurance level 10-6; single use, do not reuse
Application Expel the full 30 mL at the bleeding source, pack gauze into the wound on top of the gel, hold moderate palm pressure for three minutes or until hemostasis
Removal Within 24 hours, at the emergency department, with saline-soaked gauze and saline lavage
Storage Dry, ambient 20 to 25 C (68 to 77 F); use by the expiration date printed on the pouch; use as soon as opened and discard unused contents
Contraindications Temporary external use only; not for surgical use; not a wound-closure device; not for wounds into the thoracic cavity (intrapleural) or abdominal cavity (intraperitoneal)
Warnings Single use only; do not use on individuals with known sensitivity to sodium alginate or poly(N-acetyl-D-glucosamine, D-glucosamine); if irritation occurs flush with saline or water until clear; do not inject intravascularly
Biocompatibility Tested per ISO 10993-1:2018 as a surface device with limited contact (24 hours or less)
Use with Standard gauze packed on top of the gel, plus a pressure dressing if needed to maintain pressure (both sold separately)

Complete the Bleeding Control Kit

The Instructions for Use call for gauze over the gel and, if needed, a pressure dressing. Both are available, along with the rest of the hemostatic agents line.

What's Included

  • One Cresilon TRAUMAGEL 30 mL prefilled syringe with applicator tip and cap, sealed in a sterile pouch with the lot number and expiration date on the label
  • Nothing to mix, assemble or prepare; the pouch is opened at the point of use
  • Not included: gauze and a pressure dressing, which the Instructions for Use call for (linked above)
  • Order any quantity; each unit is one pouched syringe and one application

Who Uses This

Ground EMS and Ambulance

A no-prep syringe for moderate to severe external bleeding that is applied, covered with gauze and held for three minutes, then handed off with a 24-hour removal window.

Fire-Based EMS and Rescue

Stored dry at room temperature (20 to 25 C) alongside gauze and a pressure dressing, with no mixing or preparation when the crew reaches the patient.

Law Enforcement and Tactical Medics

Flowable gel that conforms to the wound track, used alongside a tourniquet under agency protocol and medical direction.

Hospital ED and Trauma

The receiving team removes the gel within 24 hours with saline-soaked gauze and saline lavage; the indication, contraindications and warnings are listed above.

Frequently Asked Questions

What is TRAUMAGEL?
TRAUMAGEL is a hemostatic gel made by Cresilon and indicated for temporary external use for controlling moderate to severe bleeding. It comes as a sterile, individually pouched 30 mL syringe of viscous, opaque, tan gel built from plant-based chitosan and alginate, and FDA cleared it under 510(k) K240713 in August 2024.
How does TRAUMAGEL work to stop bleeding?
Applied directly to the source of bleeding, the gel adheres to the wound site and forms a mechanical barrier that stops the flow of blood while the body creates a natural clot. It contains no thrombin or other biologics, and it works together with gauze packed on top and three minutes of palm pressure.
How is TRAUMAGEL applied, and do you still pack gauze and hold pressure?
Yes to both. Clear blood from the wound, unscrew the cap, insert the applicator tip deep in the wound as close to the bleeding source as possible, expel all 30 mL and withdraw, then pack gauze into the wound on top of the gel and hold moderate palm pressure for three minutes or until the bleeding stops.
How and when is TRAUMAGEL removed? Can it be removed in the field?
TRAUMAGEL must be removed within 24 hours of application, and removal is an emergency department procedure rather than a field step. The receiving team soaks the gauze with sterile saline, removes the entire gel, and uses saline lavage for any remnants; a misapplied dose in the field is removed the same way and replaced with a new syringe.
Is TRAUMAGEL FDA approved?
TRAUMAGEL is FDA cleared rather than FDA approved: Cresilon received 510(k) clearance K240713 on August 14, 2024, with CELOX Gauze Pro as the predicate device, and TRAUMAGEL 2.0 received clearance K253609 on December 12, 2025. Clearance means FDA found the device substantially equivalent to a legally marketed predicate.
How many syringes does a wound take? Is one syringe one application?
One syringe is one application: the directions call for expelling the entire 30 mL at the bleeding source, and the warnings state that using less than 30 mL risks loss of efficacy. If the gel is misapplied, remove it with saline-soaked gauze and repeat with a new syringe.
What is the shelf life of TRAUMAGEL and how should it be stored?
Store it dry at ambient temperature, 20 to 25 C (68 to 77 F), in its sealed pouch, and use it by the expiration date printed on the label. Use the gel as soon as the pouch is opened and discard any unused contents; because the polymers are naturally derived, the contents may look darker over time.
How is TRAUMAGEL different from QuikClot Combat Gauze, and is it in the TCCC guidelines?
TRAUMAGEL is a flowable chitosan and alginate gel delivered from a syringe and then covered with gauze, while Combat Gauze is a kaolin-impregnated gauze that is packed into the wound. Combat Gauze remains the CoTCCC hemostatic dressing of choice in the May 2026 TCCC guidelines and TRAUMAGEL is not on that list; both are available.
Does TRAUMAGEL work on patients taking blood thinners?
The labeled indication does not single out anticoagulated patients, so follow your agency protocol. A published case report describes hemostasis with TRAUMAGEL, a gauze overlay and three minutes of palm pressure on a complex scalp laceration in an 84-year-old taking clopidogrel after direct pressure and conventional hemostatic measures had failed.
Can a tourniquet be removed after applying TRAUMAGEL?
Tourniquet conversion is a protocol and medical-direction decision, not a labeled claim. In a published three-patient case series from LSU Health New Orleans and East Baton Rouge Parish EMS, TRAUMAGEL applied alongside a tourniquet achieved hemorrhage control and allowed tourniquet removal without rebleeding, and a separate hand amputation report describes tourniquet release with restored distal perfusion.
Is TRAUMAGEL plant-based, and does it contain animal products or allergens?
The polymer components are plant-based polysaccharides and are non-animal derived. Do not use TRAUMAGEL on anyone with a known sensitivity to sodium alginate or poly(N-acetyl-D-glucosamine, D-glucosamine), and if irritation occurs, flush the area with saline or water until clear.
What are TRAUMAGEL 2.0 and TRAUMAGEL Next Generation, and is the 30 mL syringe still sold?
Yes, the 30 mL syringe is still sold, and Cresilon continues to support it in the field. TRAUMAGEL 2.0 (K253609, cleared December 2025) uses the same gel and 30 mL fill with updated syringe, cap, plunger and stopper materials, and the Next Generation syringe announced in September 2026 puts the same gel in a more compact syringe.
Who uses TRAUMAGEL? Can EMTs use it?
Use follows your agency protocol and medical direction. TRAUMAGEL launched nationwide in January 2025 with regional EMS agencies, fire departments, academic medical centers and Level I trauma centers, and published agency procedures such as Miami-Dade Fire Rescue Procedure 56 place application in the hands of EMS crews.
Is this an authentic Cresilon product?
Yes. It is genuine, factory-fresh Cresilon TRAUMAGEL, sourced through authorized channels and shipped in the original sealed manufacturer pouch.
How fast does this ship?
In-stock orders typically ship within one business day. For expedited shipping, current lead times, or freight on bulk orders, contact us at CustomerService@pacificbiomedical.com or 844.436.3526.
How do I place an order, request a quote, or set up an account?
Add the item to your cart to order online, or contact us for volume pricing, GPO/contract pricing, agency purchase orders, and net terms. Reach us at CustomerService@pacificbiomedical.com or 844.436.3526.
References
  1. U.S. Food and Drug Administration. 510(k) premarket notification K240713: TRAUMAGEL hemostatic gel, Cresilon Inc. Decision date August 14, 2024. Accessed October 11, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240713.pdf
  2. Cresilon Inc. TRAUMAGEL hemostatic gel: product information and frequently asked questions. Accessed October 11, 2026. https://cresilon.com/traumagel/
  3. Miami-Dade Fire Rescue EMS Division. Procedure 56: hemostatic gel (TRAUMAGEL). Revised October 2, 2025. Accessed October 11, 2026. https://mdsceh.miamidade.gov/mobi/moms/procedure%2056.pdf
  4. Handtevy. EMS clinical procedure protocol example: TRAUMAGEL hemostatic gel. November 22, 2024. Accessed October 11, 2026. https://www.handtevy.com/wp-content/uploads/2024/12/EMS-Clinical-Procedure-Protocol-Example_11.22.2024.pdf
  5. Kleiman DJ, et al. Prehospital hemorrhage control using a novel flowable gel: an initial case series with Traumagel. Poster presentation, March 2026. Accessed October 11, 2026. https://cresilon.com/wp-content/uploads/2026/05/ATLS-Poster-Presentation_Prehospital-Hemorrhage-Control-Using-a-Novel-Flowable-Gel_An-Initial-Case-Series-With-Traumagel_March-202697.pdf
  6. Kleiman DJ, Carruth TN, Infanzon J, Nix ME, Goldstone BJ. The use of TRAUMAGEL for hemorrhage control in a complex head laceration: a case report. Open Access Emerg Med. 2025;17:339-343. doi:10.2147/OAEM.S546914
  7. Wheeler C, Greiffenstein P, Brewer J, Carruth TN, Stelly E, McCuller C. The use of Traumagel for hemorrhage control and tourniquet removal: a case series of traumatic extremity injuries. J Spec Oper Med. 2026;26(2):70-73. doi:10.55460/J.Spec.Oper.Med.2026.6ESB-BVF2
  8. Givens S, Elian J, Adam N. Prehospital emergency response in a partial hand amputation with ulnar artery transection: a case report. Int J Surg Case Rep. 2026;138(10):4042-4046. doi:10.1097/RC9.0000000000000799
  9. Nguyen JQ, Terrazas I, Ybarra J, et al. Evaluating Traumagel hemostatic device in a porcine femoral artery hemorrhage model. Transfusion. 2026;66(suppl 1):S278-S285. doi:10.1111/trf.70134
  10. Radcliffe RM, Eggert HE, Hayes GM, et al. A hemostatic hydrogel has high efficacy for the treatment of hemorrhage in a large animal randomized controlled trial. J Am Vet Med Assoc. 2026;264(5):1-7. doi:10.2460/javma.25.06.0424
  11. Committee on Tactical Combat Casualty Care. TCCC guidelines for medical personnel. May 1, 2026. Accessed October 11, 2026. https://learning-media.allogy.com/api/v1/pdf/18ccfdfc-a076-47e9-8a34-376efdd81b43/contents
  12. Cresilon Inc. Cresilon announces U.S. nationwide launch of TRAUMAGEL. January 13, 2025. Accessed October 11, 2026. https://cresilon.com/2025/01/13/cresilon-announces-u-s-nationwide-launch-of-traumagel/
  13. Cresilon Inc. TRAUMAGEL study highlights sustained hemorrhage control and tourniquet removal without rebleeding. July 7, 2026. Accessed October 11, 2026. https://cresilon.com/2026/07/07/traumagel-study-highlights-sustained-hemorrhage-control-and-tourniquet-removal-without-rebleeding/
  14. U.S. Food and Drug Administration. 510(k) premarket notification K253609: TRAUMAGEL 2.0 hemostatic gel, Cresilon Inc. Decision date December 12, 2025. Accessed October 11, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253609.pdf
  15. Cresilon Inc. Cresilon launches TRAUMAGEL Next Generation. September 30, 2026. Accessed October 11, 2026. https://cresilon.com/2026/09/30/cresilon-launches-traumagel-next-generation/
  16. U.S. National Library of Medicine. AccessGUDID device record: TRAUMAGEL, primary DI 00860007891144. Accessed October 11, 2026. https://accessgudid.nlm.nih.gov/devices/00860007891144
  17. Cresilon Inc. TRAUMAGEL online store: catalog numbers TG-30-005, TG-30-010 and TG-30-050. Accessed October 11, 2026. https://shop.traumagel.com/

Peer-reviewed citations located via PubMed. References 5, 6 and 7 include a Cresilon-employed coauthor; reference 9 is independent (U.S. Army Institute of Surgical Research). This information is provided for clinical education and does not replace your agency's protocols, medical direction, or the manufacturer's Instructions for Use.

Authorized Cresilon Distributor (USA). Genuine, factory-fresh product in the original sealed manufacturer pouch.

In-stock orders typically ship within one business day. For current lead times, expedited options, or freight on bulk orders, contact us at CustomerService@pacificbiomedical.com or 844.436.3526.

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Item # Image Price Quantity

TRAUMAGEL for EMS: 30mL Syringe

CRE-TG-30-010E-EA

 Cresilon TRAUMAGEL for EMS 30 mL Syringe, model TG-0001, sterile peel pouch with the prefilled hemostatic gel syringe, Pacific Biomedical

$130.00

ea

FDA 510(k) Cleared
TRAUMAGELGenuine TRAUMAGEL Product
Most orders ship within 1 business day
History of EMS: From Civil War Ambulances to Whole Blood
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