Catalog Number

-

Brand Name

MOVES

Version/Model Number

100696

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

K093261,K093261

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

99502777-2245-445f-ad40-212d75ebeffa

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Package DI Number

20807141000180

Quantity per Package

6

Contains DI Package

10807141000015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box