Duns Number:015954530
Device Description: Pneumatic Oxygen Conserver
Catalog Number
-
Brand Name
CYPRESS
Version/Model Number
OM-501A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2021
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"
-
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
NFB
Product Code Name
Conserver, Oxygen
Public Device Record Key
3e0deca4-668a-4dcd-b891-26d14b473b46
Public Version Date
October 18, 2021
Public Version Number
4
DI Record Publish Date
January 21, 2017
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 29 |