Catalog Number

-

Brand Name

SnuggleFit

Version/Model Number

11-15000-0010

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,K040605

Product Code

BZQ

Product Code Name

Monitor, Breathing Frequency

Public Device Record Key

9de65f97-aab2-44a8-8443-1c33eabe2c96

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

00817377022807

Quantity per Package

5

Contains DI Package

00817377022791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-