Catalog Number

-

Brand Name

MOBI

Version/Model Number

700027

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

K182495,K182495,K182495

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

bfbfc7d6-5546-4ed1-8702-e5f5e3d2e3a4

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 31, 2022

Package DI Number

10891040000276

Quantity per Package

6

Contains DI Package

00891040000279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard