Duns Number:016448669
Device Description: Medefil 1 Units/mL Heparin IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain nat Medefil 1 Units/mL Heparin IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use
Catalog Number
MIH-4425
Brand Name
Heparin Lock Flush Syringe 1 Units /mL
Version/Model Number
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
K092491,K092491,K092491
Product Code
NZW
Product Code Name
Heparin, Vascular Access Flush
Public Device Record Key
ad5e5ac2-3cff-488d-b980-6234538074f8
Public Version Date
July 07, 2020
Public Version Number
6
DI Record Publish Date
April 21, 2016
Package DI Number
50364253444253
Quantity per Package
16
Contains DI Package
30364253444259
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box