Catalog Number

HCS4714MN

Brand Name

Medline

Version/Model Number

HCS4714MN

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

K063813,K063813

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

9de30872-0d2c-4ecb-b37c-e9a11ca5412a

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 11, 2022

Package DI Number

20888277728780

Quantity per Package

25

Contains DI Package

10888277728783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE