Catalog Number

2843

Brand Name

HUDSON RCI

Version/Model Number

IPN916569

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143469,K143469

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

b7e3e0ea-301a-4013-806c-6451981226c8

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

January 06, 2022

Package DI Number

24026704718263

Quantity per Package

50

Contains DI Package

14026704718266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case