Duns Number:088302096
Catalog Number
27671-FRU
Brand Name
FRU, Hose Assy, Black Mixed Gas DISS, 2'
Version/Model Number
27671-FRU
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 10, 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)
-
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
e2d4db2e-2329-49dc-b028-51dec46fce46
Public Version Date
April 18, 2019
Public Version Number
1
DI Record Publish Date
April 10, 2019
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 |