Catalog Number

-

Brand Name

Vive

Version/Model Number

DMD1026GRY

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

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9b122a5f-d134-4590-a22f-755c55367697

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 29, 2017

Package DI Number

20818323021145

Quantity per Package

120

Contains DI Package

10818323021148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case