Braun - Braun ThermoScan PRO6000 Ear Thermometer with - KAZ USA, INC.

Duns Number:122612547

Device Description: Braun ThermoScan PRO6000 Ear Thermometer with large cradle - intended for intermittent mea Braun ThermoScan PRO6000 Ear Thermometer with large cradle - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" with UDI Datamatrix 00328785000252 and 2 boxes of 20 probe covers each.

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More Product Details

Catalog Number

-

Brand Name

Braun

Version/Model Number

PRO6000LCMNV2

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

-

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 Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

7062503d-54a7-4eab-bec4-1aaae86d5031

Public Version Date

May 27, 2020

Public Version Number

3

DI Record Publish Date

August 29, 2016

Additional Identifiers

Package DI Number

10328785000334

Quantity per Package

48

Contains DI Package

00328785000337

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"KAZ USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 97
2 A medical device with a moderate to high risk that requires special controls. 22