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

cbfe8a20-cfa7-4056-a6fc-01ea576827ba

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

March 29, 2017

Package DI Number

16944414000014

Quantity per Package

30

Contains DI Package

06944414000017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag