Duns Number:088302096
Device Description: N2O DISS x DISS 90 DEG HOSE 8'
Catalog Number
34062-90-8
Brand Name
N2O DISS x DISS 90 DEG HOSE 8'
Version/Model Number
34062-90-8
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 14, 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"
Yes
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
0e472be3-97f0-489d-9aeb-df7dd1754a53
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 28, 2022
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 |