Identity
- Trade Name
- Sentinel Chest Trauma Kit FDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- The Sentinel® Chest Trauma Kit is a comprehensive set of products that deliver an enhanced level of user confidence and improve casualty outcomes when faced with symptoms of tension pneumothorax, the third leading cause of preventable traumatic death. FDA UDI
- Model / Reference
- 08 FDA UDI
- Description
- The Sentinel® Chest Trauma Kit is a comprehensive set of products that deliver an enhanced level of user confidence and improve casualty outcomes when faced with symptoms of tension pneumothorax, the third leading cause of preventable traumatic death. FDA UDI
Identifiers
- Catalog Number
- 20-510 FDA UDI
- Primary DI / UDI-DI
- M68920510080 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Pleural catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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: Pleural catheter
Sentinel Chest Trauma Kit by Safeguard Us Operating, 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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI 7f69f1f2-1056-45e8-9e4d-08d6f058bc8e 35 fields · synced May 30, 2026