Catalog Number

2844

Brand Name

HUDSON RCI

Version/Model Number

IPN044117

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

43d9a637-ca30-4fa2-9800-8c0e335d0ae8

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

November 06, 2018

Package DI Number

24026704610321

Quantity per Package

50

Contains DI Package

14026704610324

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case