Catalog Number

015706

Brand Name

Omnistream

Version/Model Number

015706

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K012391,K012391

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

f02d9e54-e9d0-43ea-9abf-aec26bfe47b9

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

December 05, 2017

Package DI Number

20884521551760

Quantity per Package

25

Contains DI Package

10884521551763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE