Identity
- Trade Name
- F-Peep™ Valve, 10 cm H2O, Green Color EUDAMEDPEEP VALVE 10cmH2O FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- F-Peep™ Valve, 10 cm H2O, Green Color EUDAMED
- Model / Reference
- CT-20400 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770204000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04716770204000 EUDAMED
- 510(k) Number
- K160112 FDA UDI
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- Z12159080 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- PEEP valve, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5965 FDA UDI
- Market of Registration
- Croatia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
PEEP VALVE 10cmH2O by Besmed Health Business Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as PEEP valve, single-use.
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- Whisperflow CPAP Valve — Respironics Novametrix, LLC · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- O2-CPAP — Pulmodyne Inc. · Class II
- O2-CPAP — Pulmodyne Inc. · Class II
- Whisperflow CPAP Valve — Respironics Novametrix, LLC · Class II
Cleared under the same submission
K160112 also covers:
- Non-Rebreathing Valve with Manometer Port (L Type) — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 10cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 12.5cmH2O — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 12.5cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 15cmH2O — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 15cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 2.5cmH2O — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 2.5cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 20cmH2O — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 20cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 5cmH2O — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 5cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
Sources (2)
- FDA UDI 37ea9010-4b28-433a-8802-88f67f3e6727 33 fields · synced Jul 28, 2026
- EUDAMED 076853b1-2abd-4ed9-b0e2-3d6a6684cbe9 61 fields · synced Jul 28, 2026