Catalog Number

-

Brand Name

Perfect Fit

Version/Model Number

11-44100-7501

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040605,K040605,K040605

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

7ff01090-b153-4c93-b86b-91853af8eb70

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

10817377023009

Quantity per Package

10

Contains DI Package

00817377023002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-