COGNOHEALTH - Cellular Blood Pressure Monitor - COGNOTA HEALTHCARE PRIVATE LIMITED

Duns Number:860516344

Device Description: Cellular Blood Pressure Monitor

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

COGNOHEALTH

Version/Model Number

COGNO-BPM001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

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

12303884-329d-433b-ac53-c4c8f824b994

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COGNOTA HEALTHCARE PRIVATE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1