Catalog Number

-

Brand Name

VIVE

Version/Model Number

RHB2013

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

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

82cd89d7-4b92-4c87-8060-fa257e04b715

Public Version Date

December 04, 2019

Public Version Number

1

DI Record Publish Date

November 26, 2019

Package DI Number

10818323029984

Quantity per Package

24

Contains DI Package

00818323029987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case