Duns Number:043046283
Device Description: TOP-FILL Gravity Feed Transition Set with ENFit Connector
Catalog Number
VED-044-30
Brand Name
NA
Version/Model Number
VED-044-30
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 29, 2022
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
K132424,K132424
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
955189e4-f0b0-44db-a12f-12edbbd68427
Public Version Date
August 01, 2022
Public Version Number
5
DI Record Publish Date
August 25, 2017
Package DI Number
50812496010433
Quantity per Package
30
Contains DI Package
00812496010438
Package Discontinue Date
July 29, 2022
Package Status
Not in Commercial Distribution
Package Type
Cardboard Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |