Duns Number:016448669
Device Description: Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contain natural Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contain natural rubber latex, Contents and its pathway are sterile, Single Use
Catalog Number
MIS-1152
Brand Name
Normal Saline IV Flush Syriinge
Version/Model Number
2.5mL in 6mL syringe
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
K091583,K091583,K091583
Product Code
NGT
Product Code Name
Saline, Vascular Access Flush
Public Device Record Key
e9df5db3-cc2d-491c-bc26-13dc20c0b124
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
50364253111520
Quantity per Package
16
Contains DI Package
30364253111526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton