Duns Number:001660786
Device Description: Tubing only
Catalog Number
701048441
Brand Name
6ft 3/8 x 3/32 Tubing 68A
Version/Model Number
BEQ-T 20104
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
1657995e-0396-4d88-8d33-376c7ef47983
Public Version Date
December 02, 2019
Public Version Number
4
DI Record Publish Date
October 28, 2015
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 |