Identity
- Trade Name
- 4" FLAT PACKED OLAES® HEMOSTATIC BANDAGE FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- The OLAES® Hemostatic Bandage combines the globally recognized OLAES® Modular Bandage with battle tested HemCon® ChitoGauze® PRO to create the most comprehensive trauma bandage for multiple injury profiles. Both proven life-saving devices are now together in a single, easily accessible package to increase any level of pre-hospital care provider’s treatment capabilities while reducing application times and saving space in your kit. One of few CoTCCC recommended hemostatic dressings, ChitoGauze® PRO features chitosan as the hemostatic agent, is X-Ray detectable, and is located inside the bandage’s wound pad for rapid access at the point of injury. The included hemostatic gauze is located inside the bandage’s wound pad for rapid access at the point of injury. The convenience of having both products in a single kit item allows you to have more time to focus on treating your patient rather than locating and opening multiple packages. Its flat packed version easily fits into most standard IFAKs, giving you options to best fit your trauma kit space requirements. It was designed with direct input from some of the most experienced combat medics in the world, first responders here at home, and our end-users so no details are left out, making the OLAES® Hemostatic Bandage the best multi-functional piece of gear inside your kit. FDA UDI
- Model / Reference
- A FDA UDI
- Description
- The OLAES® Hemostatic Bandage combines the globally recognized OLAES® Modular Bandage with battle tested HemCon® ChitoGauze® PRO to create the most comprehensive trauma bandage for multiple injury profiles. Both proven life-saving devices are now together in a single, easily accessible package to increase any level of pre-hospital care provider’s treatment capabilities while reducing application times and saving space in your kit. One of few CoTCCC recommended hemostatic dressings, ChitoGauze® PRO features chitosan as the hemostatic agent, is X-Ray detectable, and is located inside the bandage’s wound pad for rapid access at the point of injury. The included hemostatic gauze is located inside the bandage’s wound pad for rapid access at the point of injury. The convenience of having both products in a single kit item allows you to have more time to focus on treating your patient rather than locating and opening multiple packages. Its flat packed version easily fits into most standard IFAKs, giving you options to best fit your trauma kit space requirements. It was designed with direct input from some of the most experienced combat medics in the world, first responders here at home, and our end-users so no details are left out, making the OLAES® Hemostatic Bandage the best multi-functional piece of gear inside your kit. FDA UDI
Identifiers
- Catalog Number
- 85-0024 FDA UDI
- Primary DI / UDI-DI
- 00818630015505 FDA UDI
- FDA Product Code
- MHW FDA UDI
- GMDN Term
- First aid absorbent pad/bandage FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: First aid absorbent pad/bandage
4" Flat Packed Olaes® Hemostatic Bandage by Tactical Medical Solutions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tactical Medical Solutions, Llc
Sources (1)
- FDA UDI 27ff831f-2f72-4816-8f8b-af20eca11109 35 fields · synced May 30, 2026