FDA.reportPublic FDA data

Braun

Primary DI
10328785000099
Brand
Braun
Company
KAZ, INC.
Model
IRT6020US
Catalog number
IRT6020US
Device description
Thermometer, Braun Infrared ThermoScan Ear w/21 filters - for intermittent measurement of temperature for patients of all ages, this thermometer is used with lens filters.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K103800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103800000BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERSKaz USA, Inc (A Subsidiaryof Kaz Inc)2011-01-26FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10328785000099PackageGS16In Commercial Distribution
00328785000092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032878500009910328785000099
00328785000092003287850000923287850000920328785000092

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
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-327-7226consumerrelations@kaz.com

Regulatory Flags#

DUNS number
001483890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10328785002451VicksVEV7102025-05-05
10328785002475VicksVWC775V22025-05-05
50328785524654VicksV966SP2025-05-05
00328785002355HONEYWELLHUL900B2021-09-30
00328785002461Vicks VUL9002021-09-30
10328785002352HONEYWELLHUL900B2021-09-30
10328785002468Vicks VUL9002021-09-30
00328785002034VicksVNT200US2020-09-29
20328785002038VicksVNT200US2020-09-29
10328785004820VicksV4600V22020-04-03
10328785004837HoneywellHUL535WV22020-04-03
10328785004844HoneywellHUL535BV22020-04-03
10328785004875HoneywellHUL520LV32020-04-03
10328785004882HoneywellHUL520RV32020-04-03
10328785004868HoneywellHUL520BV32020-01-28
10328785003212VicksVUL6002019-12-30

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