Duns Number:088302096
Catalog Number
34062-HT____
Brand Name
N2O DISS x DISS Hand-Tight Hose ___
Version/Model Number
34062-HT____
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 22, 2099
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
c47882cc-9db9-44fd-b6ab-bd6b3a91a3cf
Public Version Date
June 22, 2018
Public Version Number
1
DI Record Publish Date
May 22, 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 | 344 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |