Catalog Number

-

Brand Name

VIVE

Version/Model Number

RHB2008

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

IME

Product Code Name

Pack, Hot Or Cold, Reusable

Public Device Record Key

89c4e513-9688-40da-a74e-5c7247072abc

Public Version Date

February 27, 2020

Public Version Number

1

DI Record Publish Date

February 19, 2020

Package DI Number

10810041981438

Quantity per Package

1

Contains DI Package

00810041981431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case