Catalog Number

0605200

Brand Name

Supplies for COMBI *M 82

Version/Model Number

0605200

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

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

-

Product Code

KLK

Product Code Name

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

Public Device Record Key

5c231a7c-bafc-4ad4-8e79-1dc509c3571a

Public Version Date

June 24, 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

-