Duns Number:121040922
Device Description: 112" UltraSpec IV Administration Set, 15 Micron Screen, Back Check Valve, Needleless Conne 112" UltraSpec IV Administration Set, 15 Micron Screen, Back Check Valve, Needleless Connectors(3), Male Luer Lock (2.8 m) Length - Box
Catalog Number
-
Brand Name
Kew Medical
Version/Model Number
QAU5131
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
c7321a24-ca06-49aa-a491-a7853d2a99d8
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-