Identity
- Trade Name
- CPAP Accesory FDA UDI
- Generic Name
- Medical gas flowmeter, Bourdon gauge FDA UDI
- Device Name
- CPAP Pressure Meter FDA UDI
- Model / Reference
- CAP003 FDA UDI
- Description
- CPAP Pressure Meter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530020019 FDA UDI
- FDA Product Code
- BXY FDA UDI
- GMDN Term
- Medical gas flowmeter, Bourdon gauge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2350 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
Yes
FDA UDI
Category: Medical gas flowmeter, Bourdon gauge
CPAP Accesory by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 b06a069b-ca2c-4f23-825c-4b67d07e878a 34 fields · synced May 30, 2026