Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA3004WHT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KMI

Product Code Name

Monitor, Bed Patient

Public Device Record Key

0659586c-3383-4dc9-a05e-4b0fa5f41d1f

Public Version Date

August 03, 2022

Public Version Number

1

DI Record Publish Date

July 26, 2022

Package DI Number

10850041211685

Quantity per Package

50

Contains DI Package

00850041211688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case