Duns Number:016448669
Device Description: Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 3mL in 12mL Syringe, Does not contain natur Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 3mL in 12mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.
Catalog Number
MIH-4433
Brand Name
Medefil Heparin Lock Flush Syringe, 1 Unit/mL
Version/Model Number
3mL in 12mL 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
K092491,K092491,K092491
Product Code
NZW
Product Code Name
Heparin, Vascular Access Flush
Public Device Record Key
79202fac-e02e-4f2c-ab65-84188aef6153
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
December 14, 2016
Package DI Number
50364253444338
Quantity per Package
16
Contains DI Package
30364253444334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton