Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA1004

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Public Device Record Key

921629f8-5799-4802-99ab-90dc0c692c7e

Public Version Date

August 02, 2018

Public Version Number

1

DI Record Publish Date

July 02, 2018

Package DI Number

10818323023524

Quantity per Package

5

Contains DI Package

00818323023527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-