Duns Number:020275145
Device Description: Tubing, Smooth Interior, Hytrel, IMC, 22MM-48"
Catalog Number
253300
Brand Name
Tubing, Smooth Interior, Hytrel, IMC, 22MM-48"
Version/Model Number
Tubing, Smooth Interior, Hytrel, IMC, 22MM-48" - 253300
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
67973eac-8f6e-43d1-bcfd-7f240bb18abe
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
January 17, 2020
Package DI Number
00817081024913
Quantity per Package
1
Contains DI Package
00817081024906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |