Identity
- Trade Name
- Sentinel Chest Seal FDA UDI
- Generic Name
- Pneumothorax dressing FDA UDI
- Device Name
- The Sentinel® Chest Seal is a device designed to seal an open chest wound and minimize the risk of developing tension pneumothorax. 1 ea - sterile dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe FDA UDI
- Model / Reference
- 07 FDA UDI
- Description
- The Sentinel® Chest Seal is a device designed to seal an open chest wound and minimize the risk of developing tension pneumothorax. 1 ea - sterile dual vent chest seal with Sentinel 10x adhesive; 1 ea - wipe FDA UDI
Identifiers
- Catalog Number
- 20-001 FDA UDI
- Primary DI / UDI-DI
- M68920001070 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
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
Sentinel Chest Seal 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 bf7403e8-7182-464f-9352-23224a172cb3 35 fields · synced May 30, 2026