FDA.reportPublic FDA data

Braun

Primary DI
00328785000337
Brand
Braun
Company
KAZ USA, INC.
Model
PRO6000LCMNV2
Device description
"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."
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152748000Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc)2016-03-01FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10328785000334PackageGS148In Commercial Distribution
00328785000337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032878500033410328785000334
00328785000337003287850003373287850003370328785000337

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure0.7 KiloPascal1.06 KiloPascal
Storage Environment Temperature-13 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-535-6663customerservice@welchallyn.com

Regulatory Flags#

DUNS number
122612547
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00328785014303BRAUNBUA4000BUS2025-09-19
00328785000160SoftheatHP910V12019-09-04
00092926503208HoneywellHEV320B2018-03-30
00328785001334HONEYWELLHWM845B2018-08-01
00328785001723HONEYWELLHUL430W2018-08-01
00328785002362HONEYWELLHWC775B2021-09-30
00328785004083HoneywellHWM440W2020-08-17
00328785004113HoneywellHWM440B2020-08-17
00328785006247HoneywellHWC775W2021-09-30
00328785006537HoneywellHUL525B2021-10-15
00328785006544HoneywellHUL525W2021-10-15
00328785006575HoneywellHUL545B2021-10-15
00328785006612HoneywellHUL545W2021-10-15
00328785006629HoneywellHUL5302021-10-15
00328785006636HoneywellHUL565B2021-10-15
00328785004106HoneywellHWM445B2020-08-17
00328785000054BraunIRT6500US2016-09-09
00328785000092Braun IRT6020USIRT6020US2016-09-09
00328785000276VicksV912USV12016-11-04
00328785000450Kaz821-242016-09-09

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