Catalog Number

301-1013

Brand Name

Curaplex

Version/Model Number

301-1013

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

-

Product Code

BYD

Product Code Name

CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Public Device Record Key

2e826bef-af9f-46f4-b53a-4280a6cd7580

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 27, 2017

Package DI Number

00812574025958

Quantity per Package

25

Contains DI Package

00812574025941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-