Vive Precision - Bluetooth Blood Pressure Monitor Black - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Bluetooth Blood Pressure Monitor Black

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More Product Details

Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1039BLK

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)

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

c4e77bc3-dc9f-42a6-ac53-228b29c68a3d

Public Version Date

November 09, 2018

Public Version Number

1

DI Record Publish Date

October 09, 2018

Additional Identifiers

Package DI Number

10818323024859

Quantity per Package

10

Contains DI Package

00818323024852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"VIVE HEALTH LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 87