Identity
- Trade Name
- Wound Seal Kit FDA UDI
- Generic Name
- Pneumothorax dressing FDA UDI
- Device Name
- Wound Seal Kit provides a fast application for sealing wounds quickly to stop external bleeding. The Wound Seal Kit is a sterile, TCCC - compliant occlusive dressing that comes vacuum sealed with a 6 x 8 inch plastic sealing rectangle and hydrogel adhesive to stick to the wound and the surrounding skin through blood and debris. Along with the wound seal, the kit comes with a sterile 4 x 7.5 inch ABD Pad. The Wound Seal Kit is especially applicable for chest exit wounds or additional chest wounds when used in conjunction with the BCS Chest Seal. FDA UDI
- Model / Reference
- 05 FDA UDI
- Description
- Wound Seal Kit provides a fast application for sealing wounds quickly to stop external bleeding. The Wound Seal Kit is a sterile, TCCC - compliant occlusive dressing that comes vacuum sealed with a 6 x 8 inch plastic sealing rectangle and hydrogel adhesive to stick to the wound and the surrounding skin through blood and debris. Along with the wound seal, the kit comes with a sterile 4 x 7.5 inch ABD Pad. The Wound Seal Kit is especially applicable for chest exit wounds or additional chest wounds when used in conjunction with the BCS Chest Seal. FDA UDI
Identifiers
- Catalog Number
- HHWSK02 FDA UDI
- Primary DI / UDI-DI
- M689HHWSK02050 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Pneumothorax dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 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
Yes
FDA UDI
Convenience Kit
Yes
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: Pneumothorax dressing
Wound Seal Kit by Safeguard Us Operating, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumothorax dressing.
- SAM Chest Seal — SAM Medical Products · Class I
- SAM Chest Seal — SAM Medical Products · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- FOXSEAL — Medtrade Products , Ltd. · Class I
- FOXSEAL Vented — Medtrade Products , Ltd. · Class I
- Russell Chest Seal (US Version) — SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Class I
- Wound Seal Duo — H & H Medical Corporation · Class I
- MedSource Halo Chest Seal — MEDSOURCE INTERNATIONAL LLC · Class I
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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI 0a6bb68d-6b72-432e-bb31-d404adb9e9fa 35 fields · synced May 30, 2026