MOBI - MOBI Health Wrist Blood Pressure Monitor - MOBI TECHNOLOGIES, INC.

Duns Number:137468570

Device Description: MOBI Health Wrist Blood Pressure Monitor (Sphygmomanometers)

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More Product Details

Catalog Number

-

Brand Name

MOBI

Version/Model Number

70167

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

2c9a36c4-7a79-4ffc-8d67-87f61a3a0d76

Public Version Date

December 31, 2020

Public Version Number

6

DI Record Publish Date

September 07, 2017

Additional Identifiers

Package DI Number

20891040701675

Quantity per Package

24

Contains DI Package

00891040701671

Package Discontinue Date

December 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Cardboard

"MOBI TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6