Catalog Number

301-4000-AST

Brand Name

Curaplex

Version/Model Number

301-4000-AST

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

K143127,K143127,K143127

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

d87c5332-6e34-4b04-adba-738fe4d67dc7

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2019

Package DI Number

00818834028240

Quantity per Package

25

Contains DI Package

00818834028189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX