Catalog Number

-

Brand Name

VIVE

Version/Model Number

RHB1035

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

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

da5d0a7d-6507-49f5-b69e-33c160e55d1b

Public Version Date

March 22, 2019

Public Version Number

1

DI Record Publish Date

March 14, 2019

Package DI Number

10818323020912

Quantity per Package

40

Contains DI Package

00818323020915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case