Identity
- Trade Name
- Russell Chest Seal (US Version) FDA UDI
- Generic Name
- Pneumothorax dressing FDA UDI
- Device Name
- The Russell Chest Seal® is a hydrogel-based dressing with an integral low-profile, four apertures, valve. The base material of the chest seal is a hydrogel matrix, which comprises a water-containing gel, mounted onto a non-woven fabric with silicon coated release liners. The Russell Chest Seal® is used to cover penetrating chest wounds, and the valve mechanism allows air to escape from the pleural cavity without being drawn back in. This aims to minimise lunge collapse associated with this injury and to facilitate lung re-inflation. The device will remain adhered over many hours and is comfortable for the patient in prolonged use (up to 24 hours). FDA UDI
- Model / Reference
- PDF0680 FDA UDI
- Description
- The Russell Chest Seal® is a hydrogel-based dressing with an integral low-profile, four apertures, valve. The base material of the chest seal is a hydrogel matrix, which comprises a water-containing gel, mounted onto a non-woven fabric with silicon coated release liners. The Russell Chest Seal® is used to cover penetrating chest wounds, and the valve mechanism allows air to escape from the pleural cavity without being drawn back in. This aims to minimise lunge collapse associated with this injury and to facilitate lung re-inflation. The device will remain adhered over many hours and is comfortable for the patient in prolonged use (up to 24 hours). FDA UDI
Identifiers
- Catalog Number
- PDF0680 FDA UDI
- Primary DI / UDI-DI
- 05060483570365 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Pneumothorax dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
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: Pneumothorax dressing
Russell Chest Seal (US Version) by Safeguard Medical Technologies Limited — 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
- Chest Wound Seal Kit — SAFEGUARD US OPERATING, LLC · Class I
- Wound Seal Duo — H & H Medical Corporation · Class I
- Sentinel Chest Seal — SAFEGUARD US OPERATING, 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 Medical Technologies Limited
Sources (1)
- FDA UDI fa86f4a7-1f79-4614-b6df-756023508736 35 fields · synced May 31, 2026