Identity
- Trade Name
- Sentinel Chest Trauma Kit FDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- SENTINEL CHEST TRAUMA KIT 2 ea Sentinel Dual vent Chest seals with Sentinel 10x extreme strength adhesive 1 ea Dart sterile 14 gauge x 3.25" needle / catheter for chest decompression 1 ea Dart Target 1 ea wipe FDA UDI
- Model / Reference
- 03 FDA UDI
- Description
- SENTINEL CHEST TRAUMA KIT 2 ea Sentinel Dual vent Chest seals with Sentinel 10x extreme strength adhesive 1 ea Dart sterile 14 gauge x 3.25" needle / catheter for chest decompression 1 ea Dart Target 1 ea wipe FDA UDI
Identifiers
- Catalog Number
- 20-510 FDA UDI
- Primary DI / UDI-DI
- M68920510030 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
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 824d1735-2e59-4fe5-be16-bbbcbf13b53b 36 fields · synced May 30, 2026