Catalog Number

048400-10

Brand Name

H3 Cartridge

Version/Model Number

049220

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CHL

Product Code Name

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Public Device Record Key

cfde495f-5124-42ea-bfc6-aff2d0cbd2d7

Public Version Date

May 24, 2018

Public Version Number

1

DI Record Publish Date

April 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-