Duns Number:015954530
Device Description: INT-812 CONSERVER WITH M9 OXYGEN CYLINDER
Catalog Number
-
Brand Name
BONSAI
Version/Model Number
INT-812M9
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"
-
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
8c5969fa-0524-4149-ba9e-ec7d87927cbd
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
May 11, 2018
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 |