Duns Number:058716649
Device Description: "Twist & Go HPCT, CoEx, 20''(SET,PACKAGED,TWIST-GO,CO-EX,20"",UV,MC,JA)(84196762)"
Catalog Number
TAG C50 HPCT
Brand Name
MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in)
Version/Model Number
TAG C50 HPCT
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"
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
K131517,K131517
Product Code
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
34cbfe70-b02c-4016-8b72-6741de0211a0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10616258007103
Quantity per Package
25
Contains DI Package
00616258007106
Package Discontinue Date
December 31, 9999
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |