Identity
- Trade Name
- DAR FDA UDI
- Generic Name
- PEEP valve, reusable FDA UDI
- Device Name
- 2-Way Exhalation Valve FDA UDI
- Model / Reference
- 111P1160 FDA UDI
- Description
- 2-Way Exhalation Valve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521784673 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- PEEP valve, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: PEEP valve, reusable
Dar by Covidien LP — Class I — 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
- Non-Rebreathing Valve with Manometer Port (L Type) — BESMED HEALTH BUSINESS CORP. · Class II
- OxyPAP — D R BURTON HEALTHCARE, LLC · Class II
- Reusable PEEP 10 valve — Ambu A/S · Class II
- Pressure Valve — Respironics, Inc. · Class II
- BE 30-142 — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
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 8f8e76fc-7785-49ff-9abb-892c2c16bd37 34 fields · synced May 30, 2026