Duns Number:016448669
Device Description: Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex Medefil Normal Saline IV Flush Syringe, 1mL in 6mL syringe, does not contain natural latex rubber or preservatives, contents and its pathway are sterile. Single Use.
Catalog Number
MIS-1121
Brand Name
Normnal Saline I.V. Flush Syringe
Version/Model Number
1mL 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
Yes
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
f6484569-805f-41b2-9242-5958bc7d4f00
Public Version Date
November 22, 2018
Public Version Number
5
DI Record Publish Date
December 09, 2016
Package DI Number
50364253111216
Quantity per Package
16
Contains DI Package
30364253111212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton