Duns Number:088302096
Device Description: N2 DISS Hand-Tight 90° x 1/2" Schrader FQC
Catalog Number
35005
Brand Name
N2 DISS Hand-Tight 90° x 1/2" Schrader FQC
Version/Model Number
35005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 01, 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
0c22a3ba-2694-4535-add3-22ca957d5e68
Public Version Date
June 01, 2018
Public Version Number
1
DI Record Publish Date
May 01, 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 |