Vive Precision - Sphygmomanometer - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Sphygmomanometer

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More Product Details

Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1013

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"

Yes

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

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

2788f4e6-0644-4ffe-8cc9-5337a74274c9

Public Version Date

November 02, 2020

Public Version Number

6

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

10818323020271

Quantity per Package

50

Contains DI Package

00818323020274

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