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Laerdal Disposable PEEP Valve Assembly
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 845140Model Laerdal Disposable PEEP, Valve Assembly
Identity
- Trade Name
- Laerdal Disposable PEEP Valve Assembly EUDAMEDFDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- The BAG II Disposable Resuscitator EUDAMEDThe Laerdal Disposable PEEP Valve Assembly is a single patient use accessory for use with all models of Laerdal brand resuscitators to enable clinicians to apply and adjust the level of PEEP therapy being administered to a patient. The PEEP Valve connector is the standard 30 mm ID size FDA UDI
- Model / Reference
- Laerdal Disposable PEEP, Valve Assembly EUDAMED845140 EUDAMEDFDA UDI
- Description
- The Laerdal Disposable PEEP Valve Assembly is a single patient use accessory for use with all models of Laerdal brand resuscitators to enable clinicians to apply and adjust the level of PEEP therapy being administered to a patient. The PEEP Valve connector is the standard 30 mm ID size FDA UDI
Identifiers
- Catalog Number
- 845140 FDA UDI
- Primary DI / UDI-DI
- 07045432082500 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07045432082500 EUDAMED
- FDA Product Code
- BYE FDA UDI
- EMDN Code
- R030280 RESPIRATORY BALLONS - 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
- Norway EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Laerdal Disposable PEEP Valve Assembly by Laerdal Medical AS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07045432082500 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (2)
- EUDAMED 4159b081-b74b-4a50-bfe6-31bf7b32903b 61 fields · synced Jul 9, 2026
- FDA UDI 839937f6-82b2-48a0-a4b3-88d9d719c9c8 37 fields · synced May 30, 2026