Catalog Number

-

Brand Name

VIVE

Version/Model Number

LVA2025

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

ILS

Product Code Name

Adaptor, Hygiene

Public Device Record Key

29a5d85c-12ae-40bf-ad94-565ed2efefff

Public Version Date

February 03, 2020

Public Version Number

1

DI Record Publish Date

January 24, 2020

Package DI Number

10810041981223

Quantity per Package

1

Contains DI Package

00810041981226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case