Catalog Number

RHET45U

Brand Name

HUDSON RCI

Version/Model Number

IPN916682

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

K961150,K961150

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

f02f91fd-bd00-4330-88a8-eb2b023a38d6

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2020

Package DI Number

24026704717877

Quantity per Package

25

Contains DI Package

14026704717870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case