Catalog Number

-

Brand Name

Curaplex

Version/Model Number

301-P3602

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

K151421,K151421

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

0b5fdae0-b0a3-4782-8350-4579a68d21c4

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2016

Package DI Number

00812574025903

Quantity per Package

25

Contains DI Package

00812574025910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-