Duns Number:117970217
Catalog Number
-
Brand Name
KENTEC EXTENSION SET
Version/Model Number
KMI467C
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
K955896,K955896
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
90e4f9df-6719-491b-96d3-8b3bdddc2ec5
Public Version Date
September 01, 2022
Public Version Number
1
DI Record Publish Date
August 24, 2022
Package DI Number
10810080610429
Quantity per Package
50
Contains DI Package
00810080610422
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 103 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |