Duns Number:121040922
Device Description: 14" IV Minibore Extension Set, Needleless Connector(Removable), Male Luer Lock (0.36 m) Le 14" IV Minibore Extension Set, Needleless Connector(Removable), Male Luer Lock (0.36 m) Length- Box
Catalog Number
-
Brand Name
Kew Medical
Version/Model Number
QEG6132
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
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
c150584e-60f4-4bfc-8dd8-12e7f5101687
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-