Catalog Number

-

Brand Name

Curaplex

Version/Model Number

301-PFR9WE2

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

K042758,K042758

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

5a0b4786-25e4-4636-b974-3f226d25702a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 06, 2017

Package DI Number

00812574026757

Quantity per Package

100

Contains DI Package

00812574026405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-