Health Team - Thermometer, Disposable - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: Thermometer, Disposable

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Health Team

Version/Model Number

1858CASE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

e3081c14-cea9-45e1-b8f2-c7c1d9631ad2

Public Version Date

July 25, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

M3681858CASE2

Quantity per Package

10

Contains DI Package

M3681858CASE1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202