Duns Number:305682023
Device Description: Ambu PEEP valve 10, for baby resuscitators with connector, ID 18 mm, for Ambu Paedi valves
Catalog Number
A000138000
Brand Name
Reusable PEEP 10 valve
Version/Model Number
A000138000
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
f610a8cd-ca96-44d5-9657-22d1bbca5433
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 07, 2016
Package DI Number
05707480015023
Quantity per Package
40
Contains DI Package
05707480029617
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 |