Duns Number:656854379
Catalog Number
Disposable Adjustable Peep Valve 5-20cm H O, 22mmID, Blue
Brand Name
N/A
Version/Model Number
2421
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
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
3186098d-fa1d-42df-8f7c-7b4b69750e96
Public Version Date
October 26, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
44710810083691
Quantity per Package
50
Contains DI Package
04710810083693
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |