Catalog Number

-

Brand Name

Curaplex

Version/Model Number

301-4900EA

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BZH

Product Code Name

METER, PEAK FLOW, SPIROMETRY

Public Device Record Key

e7fc2fb9-f251-4e47-97e5-d825d160a683

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 22, 2017

Package DI Number

00812574025415

Quantity per Package

100

Contains DI Package

00812574025422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-