Catalog Number

-

Brand Name

Pure Comfort Peak Flow Meter ADULT

Version/Model Number

EP70101

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

-

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

CAX

Product Code Name

Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Public Device Record Key

9ccf1a29-5995-4c51-9369-8a13ab94c7fa

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

Package DI Number

10860000526590

Quantity per Package

25

Contains DI Package

00860000526593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton