Duns Number:305682023
Device Description: PEEP Valve 20, Disposable, EA
Catalog Number
199002001
Brand Name
Disposable PEEP 20 valve
Version/Model Number
199002001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 2022
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"
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
e96adb4b-7d93-4478-a73d-a918ed8fe3fb
Public Version Date
February 03, 2022
Public Version Number
3
DI Record Publish Date
January 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |