Catalog Number

-

Brand Name

VIVE

Version/Model Number

LVA2045

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

KHA

Product Code Name

Mask, Scavenging

Public Device Record Key

db12ead1-f2c2-459e-a30d-21f68b159d09

Public Version Date

April 14, 2020

Public Version Number

1

DI Record Publish Date

April 06, 2020

Package DI Number

10810041981759

Quantity per Package

100

Contains DI Package

00810041981752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case