Duns Number:730624095
Device Description: The Laerdal Disposable PEEP Valve Assembly is a single patient use accessory for use with 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
Catalog Number
845140
Brand Name
Laerdal Disposable PEEP Valve Assembly
Version/Model Number
845140
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
839937f6-82b2-48a0-a4b3-88d9d719c9c8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 22, 2017
Package DI Number
07045432084108
Quantity per Package
10
Contains DI Package
07045432082500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 80 |