Identity
- Trade Name
- FireSafe Cannula Kit FDA UDI
- Generic Name
- Oxygen tubing fire safety valve FDA UDI
- Device Name
- Firesafe Kits Contains: 10 - AMRS001FiresafeKit FDA UDI
- Model / Reference
- AMRS001FiresafeKit-10 FDA UDI
- Description
- Firesafe Kits Contains: 10 - AMRS001FiresafeKit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530105143 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Oxygen tubing fire safety valve FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxygen tubing fire safety valve
FireSafe Cannula Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen tubing fire safety valve.
- Firesafe Connector Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Firesafe Valve and Nozzle Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Firesafe Connector Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- FireSafe Cannula Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Oxygen Connector/Adapter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Firesafe Cannula Valve — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Firesafe Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Firesafe Cannula Valves — SUNSET HEALTHCARE SOLUTIONS, Inc.
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 85869d0a-1aeb-43b3-8052-fea118850620 34 fields · synced Jun 8, 2026