Identity
- Trade Name
- Oxygen Kit FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Device Name
- Invacare Platinum Kit with Humidifier This kit contains: (2) OF9002, (1) BFH6S, (1) BF1438, (1) RES050, (1) HUM008 FDA UDI
- Model / Reference
- APAR008PLATINUMKITB FDA UDI
- Description
- Invacare Platinum Kit with Humidifier This kit contains: (2) OF9002, (1) BFH6S, (1) BF1438, (1) RES050, (1) HUM008 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530083960 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
Yes
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 administration kit
Oxygen Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 1fa73d0c-0792-4eca-b0fc-51606cc9823f 34 fields · synced May 30, 2026