Duns Number:305682023
Device Description: Ambu PEEP valve 10, complete for adult and baby resuscitators with connector, ID 30 mm for Ambu PEEP valve 10, complete for adult and baby resuscitators with connector, ID 30 mm for adult patient valves, and connector ID 18 mm for Ambu Paedi valves
Catalog Number
A137001000
Brand Name
Reusable PEEP 10 valve
Version/Model Number
A137001000
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"
Yes
For Single-Use
-
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
fbda0cdb-9f81-4226-b2e1-f42fb324f2df
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 07, 2016
Package DI Number
05707480015429
Quantity per Package
40
Contains DI Package
05707480030668
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 |