Identity
- Trade Name
- OxyPAP FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851232007711 FDA UDI
- 510(k) Number
- K192000 FDA UDI
- FDA Product Code
- BWF FDA UDICAP FDA UDI
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5690 FDA UDI868.2600 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
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
Yes
FDA UDI
Category: Venturi oxygen face maskAirway pressure monitor, non-poweredIncentive spirometerPEEP valve, reusable
OxyPAP by D R Burton Healthcare, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as PEEP valve, reusable.
- Reusable PEEP 20 valve — Ambu A/S · Class II
- EM — Allied Medical LLC · Class II
- Babi.Plus — Galemed Corp. · Class II
- DAR — Covidien LP · Class I
- DAR — Covidien LP · Class I
- Non-Rebreathing Valve with Manometer Port (L Type) — BESMED HEALTH BUSINESS CORP. · Class II
- DAR — Covidien LP · Class I
- Reusable PEEP 10 valve — Ambu A/S · Class II
Cleared under the same submission
K192000 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 II | Pending data |
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Manufacturer
- Manufacturer
- D R Burton Healthcare, Llc
Sources (1)
- FDA UDI 540ca6ce-3688-4c71-846c-c95a98eb75d3 35 fields · synced May 29, 2026