Catalog Number

0605000

Brand Name

COMBI *M sensor 82

Version/Model Number

0605000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 07, 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

c77f0260-8f32-4539-9ef9-ef122a55db88

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

-