Catalog Number

-

Brand Name

Med-link

Version/Model Number

S0044D-S

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

-

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

K083010,K083010

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

1386905f-166b-4467-a47d-4b514c6cde04

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

March 30, 2017

Package DI Number

16944414012321

Quantity per Package

14

Contains DI Package

06944414012324

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag