Catalog Number

-

Brand Name

Med-link

Version/Model Number

S0136J-L

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

K113727,K113727,K113727

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

2a0d5103-8574-4280-ba77-f9f69522ece4

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

March 30, 2017

Package DI Number

16944414037966

Quantity per Package

24

Contains DI Package

06944414037969

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box