DEVICE: Braun (00328785000344)

Device Identifier (DI) Information

Braun
PRO6000KSNA
In Commercial Distribution

KAZ, INC.
00328785000344
GS1

1
001483890 *Terms of Use
Braun ThermoScan PRO6000 Ear Thermometer with Small Cradle & Charging Station - 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 a box of 20 probe covers.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Infrared patient thermometer, ear A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between .7 and 1.06 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -13 and 131 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5f972f5d-516c-4822-a448-85ef5cc95b54
March 29, 2018
2
August 29, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10328785000341 18 00328785000344 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
1-800-535-6663
customerservice@welchallyn.com
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