Catalog Number

-

Brand Name

Curaplex

Version/Model Number

301-PFR8WE2

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

da845ab2-234e-4619-98fb-76621c8e4159

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

00812574024029

Quantity per Package

100

Contains DI Package

00812574024821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-