Catalog Number

-

Brand Name

Mediplus

Version/Model Number

A202Ax-D-M

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

K131339,K131339

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

603f1b8c-5dad-403d-a0d9-f5cef807656c

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 19, 2021

Package DI Number

15055140704037

Quantity per Package

50

Contains DI Package

05055140704030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton