Identity
- Trade Name
- Puritan Bennett FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- Narrow Vent Shell,For Soft Headgear CPAP Interface Circuit FDA UDI
- Model / Reference
- S-232100-00B FDA UDI
- Description
- Narrow Vent Shell,For Soft Headgear CPAP Interface Circuit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884521134468 FDA UDI
- 510(k) Number
- K890193 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Puritan Bennett by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K890193 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 317986da-7158-48bb-b011-d9459f82f4ea 36 fields · synced May 31, 2026