VIVE - Compression Gloves - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Compression Gloves

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


More Product Details

Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP1019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 30, 2022

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

MHW

Product Code Name

Dressing, Compression

Device Record Status

Public Device Record Key

adf0cf8c-bc9b-446d-9260-978fbb7893b6

Public Version Date

October 04, 2022

Public Version Number

3

DI Record Publish Date

July 03, 2019

Additional Identifiers

Package DI Number

10818323028123

Quantity per Package

100

Contains DI Package

00818323028126

Package Discontinue Date

November 30, 2022

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