Catalog Number

ZML-9450-1

Brand Name

N/A

Version/Model Number

ZML-9450-1

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"

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

K930957,K930957

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

0197bda8-7dc5-4ce2-835c-122149cb1f7c

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

March 12, 2018

Package DI Number

10607411950961

Quantity per Package

5

Contains DI Package

00607411950964

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-