Identity
- Trade Name
- Respiratory Kit FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- This kit contains: 1 CM005L Deluxe Full Face CPAP Mask - Large, 1 TUB06 Durable CPAP Tubing - 6ft, 1 RES019 Oxygen Enrichment Adapter, 1 RES3015 Oxygen Supply. Tube - 15ft. FDA UDI
- Model / Reference
- AISIOO1CM005L FDA UDI
- Description
- This kit contains: 1 CM005L Deluxe Full Face CPAP Mask - Large, 1 TUB06 Durable CPAP Tubing - 6ft, 1 RES019 Oxygen Enrichment Adapter, 1 RES3015 Oxygen Supply. Tube - 15ft. FDA UDI
Identifiers
- Catalog Number
- AISIOO1CM005L FDA UDI
- Primary DI / UDI-DI
- 00848530080792 FDA UDI
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: CPAP/BPAP face mask, reusable
Respiratory Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI c5243194-4a79-4127-9934-6e702a99a94a 35 fields · synced May 30, 2026