Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1035WHT

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

K171578,K171578

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a4d1a603-07bd-4ebd-84f2-464b0d95d706

Public Version Date

September 03, 2018

Public Version Number

1

DI Record Publish Date

August 02, 2018

Package DI Number

10818323023548

Quantity per Package

50

Contains DI Package

00818323023541

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case