Identity
- Trade Name
- KENOREX FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- PEEP VALVE DISPOSABLE 5-20 CMS WATER PRESSURE, 30 MM ID FDA UDI
- Model / Reference
- 712320 FDA UDI
- Description
- PEEP VALVE DISPOSABLE 5-20 CMS WATER PRESSURE, 30 MM ID FDA UDI
Identifiers
- Catalog Number
- 712320 FDA UDI
- Primary DI / UDI-DI
- 10852244007379 FDA UDI
- 510(k) Number
- K160112 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: PEEP valve, single-use
Kenorex by Kentron Health Care, Inc. — 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
K160112 also covers:
- Non-Rebreathing Valve with Manometer Port (L Type) — BESMED HEALTH BUSINESS CORP.
- PEEP VALVE 10cmH2O — 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.
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
- Kentron Health Care, Inc.
Sources (1)
- FDA UDI f21d1f52-7712-4198-84b4-4b57879e843b 36 fields · synced May 29, 2026