Catalog Number

-

Brand Name

Vive

Version/Model Number

RHB1049RPK

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

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

7e8b2689-2990-4d03-9a54-315f33ac6330

Public Version Date

December 08, 2021

Public Version Number

1

DI Record Publish Date

November 30, 2021

Package DI Number

10810041988130

Quantity per Package

20

Contains DI Package

00810041988133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case