Catalog Number

2857

Brand Name

HUDSON RCI

Version/Model Number

IPN044130

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"

-

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

f676fa1f-8255-4232-93da-3ca7444cd0fe

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

44026704589850

Quantity per Package

50

Contains DI Package

04026704589852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case