Duns Number:001660786
Catalog Number
701048443
Brand Name
6ft 3/8 x 3/32 Tubing
Version/Model Number
T 20104
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2021
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
Yes
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
DWE
Product Code Name
Tubing, Pump, Cardiopulmonary Bypass
Public Device Record Key
a5eca0ea-6cfe-45d0-a73a-ff7b3685e190
Public Version Date
June 07, 2021
Public Version Number
5
DI Record Publish Date
March 25, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 663 |