Catalog Number

-

Brand Name

TruPeak®

Version/Model Number

Peak Flow Meter, cs/100

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

-

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

K031514,K031514

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

bf45bec2-08d4-417f-a57e-376c89930245

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

50604351915010

Quantity per Package

100

Contains DI Package

00604351915015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-