Catalog Number

-

Brand Name

Med-link

Version/Model Number

Y000P10

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

-

Product Code

KZD

Product Code Name

Infusor, Pressure, For I.V. Bags

Public Device Record Key

888633f0-f6da-4c84-9832-6f812fb26868

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

March 30, 2017

Package DI Number

16944414029541

Quantity per Package

24

Contains DI Package

06944414029544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box