Identity
- Trade Name
- Pressure Safe FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Device Name
- Pressure Safe CO-Flo, Disposable Heated Humidified Circuit Kit FDA UDI
- Model / Reference
- 9655PS FDA UDI
- Description
- Pressure Safe CO-Flo, Disposable Heated Humidified Circuit Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078005749 FDA UDI
- FDA Product Code
- OGL FDA UDI
- GMDN Term
- Oxygen administration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5655 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oxygen administration kit
Pressure Safe by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
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- Cylinder Wrench for Tank Valve - Without Chain — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Oxygen Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Westmed, Inc.
Sources (1)
- FDA UDI 2de4c3f9-716a-4b8c-a41d-c18ceba6aa65 33 fields · synced May 30, 2026