Catalog Number

MIH-3330

Brand Name

Medefil Heparin Lock Flush Syringe, 100 Unit/mL

Version/Model Number

10mL 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

0a7640dc-6c9d-4cce-a7d2-762816d6ee9a

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

December 14, 2016

Package DI Number

50364253333304

Quantity per Package

16

Contains DI Package

30364253333300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton