Catalog Number

-

Brand Name

Perfect Fit

Version/Model Number

11-14001-5001

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

K040605,K040605

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

ca4248c3-9328-46ca-970b-da2b8baecc21

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

10817377020138

Quantity per Package

5

Contains DI Package

00817377020131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-