Geratherm Baby ColorChoice Blue Digital Thermometer - Digital thermometer with backlight, 10 second - R.G. ENTERPRISES (U.S.A.), INC.

Duns Number:928998905

Device Description: Digital thermometer with backlight, 10 second readings, beeps when ready, flextip, jumbo d Digital thermometer with backlight, 10 second readings, beeps when ready, flextip, jumbo display, waterproof, auto shut-off, dual scale provided with protective case.

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More Product Details

Catalog Number

30061

Brand Name

Geratherm Baby ColorChoice Blue Digital Thermometer

Version/Model Number

RETAIL Blue Digital Thermometer w- backlight

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K070028

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

8c173c7e-0aa6-4fc5-9d34-13b68d972acd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"R.G. ENTERPRISES (U.S.A.), INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 17