Duns Number:305682023
Device Description: Ambu Disposable PEEP valve; 20 pcs/20 mm
Catalog Number
199002020
Brand Name
Disposable PEEP 20 valve
Version/Model Number
199002020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
6df66b31-aeff-4078-a91b-a981cbd56abd
Public Version Date
June 15, 2018
Public Version Number
3
DI Record Publish Date
January 07, 2016
Package DI Number
05707480034314
Quantity per Package
20
Contains DI Package
05707480030705
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |