Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA1087OS

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

ESD

Product Code Name

Hearing Aid, Air Conduction

Public Device Record Key

8c7db73a-ddcc-4a57-a82e-152f9ff682b9

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

March 20, 2019

Package DI Number

10818323023036

Quantity per Package

150

Contains DI Package

00818323023039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case