Catalog Number

0607110

Brand Name

Application set

Version/Model Number

0607110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 25, 2019

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"

-

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

-

Product Code

KLK

Product Code Name

Monitor, oxygen, cutaneous, for infant not under gas anesthesia

Public Device Record Key

26f0a520-5291-4d08-b74c-deb023886b97

Public Version Date

June 22, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-