Catalog Number

87-639-000

Brand Name

TOPCARE

Version/Model Number

87-639-000

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

K962520,K962520

Product Code

OZK

Product Code Name

Thermometer, Exhaled Breath

Public Device Record Key

31ab3c3c-2049-4cc1-8719-d0a583006bd5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

10036800396927

Quantity per Package

72

Contains DI Package

00036800396920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner/Master Carton