Duns Number:020275145
Device Description: Tubing, Smooth Interior, Hytrel, IMC, 22MM-36"
Catalog Number
253200
Brand Name
Tubing, Smooth Interior, Hytrel, IMC, 22MM-36"
Version/Model Number
Tubing, Smooth Interior, Hytrel, IMC, 22MM-36" - 253200
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
599b5605-8f29-45b3-a938-c335091c922e
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
January 17, 2020
Package DI Number
00817081024890
Quantity per Package
1
Contains DI Package
00817081024883
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 |