Identity
- Trade Name
- Disposable PEEP Valve FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- Disposable PEEP valve for use on the Rescuer manual resuscitator. FDA UDI
- Model / Reference
- 4000-PEEP FDA UDI
- Description
- Disposable PEEP valve for use on the Rescuer manual resuscitator. FDA UDI
Identifiers
- Catalog Number
- 4000-PEEP FDA UDI
- Primary DI / UDI-DI
- B0024000PEEP0 FDA UDI
- 510(k) Number
- K981415 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- PEEP valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5965 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: PEEP valve, single-use
Disposable PEEP Valve by B.L.S. Systems Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as PEEP valve, single-use.
- PEEP VALVE 5cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · Class II
- PEEP VALVE 2.5cmH2O — BESMED HEALTH BUSINESS CORP. · Class II
- O2-CPAP — Pulmodyne Inc. · Class II
- PEEP VALVE 10cmH2O — BESMED HEALTH BUSINESS CORP. · Class II
- O2-CPAP — Pulmodyne Inc. · Class II
- AirLife™ — Airlife, Inc. · Class II
- Whisperflow CPAP Valve — Respironics Novametrix, LLC · Class II
- PEEP VALVE 15cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · Class II
Cleared under the same submission
K981415 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
- B.L.S. Systems Limited
Sources (1)
- FDA UDI fc3be768-2261-4677-bfae-636bf84b2e14 37 fields · synced Jun 6, 2026