Catalog Number

301-44F10-120

Brand Name

Curaplex

Version/Model Number

301-44F10-120

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153441,K153441,K153441

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

ef71f478-5b66-429a-9ee0-ef523c4100fc

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

April 18, 2017

Package DI Number

00818834020367

Quantity per Package

10

Contains DI Package

00818834020343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX