FDA.reportPublic FDA data

Exergen Temporal Scanner

Primary DI
00834098000563
Brand
Exergen Temporal Scanner
Company
EXERGEN CORPORATION
Model
TAT-5000S-MUSB
Catalog number
124269-AC-GE
Device description
TAT-5000S-MUSB Arterial Calibration - Celsius
Published
2023-06-21
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
K011291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011291000TEMPORALSCANNER THERMOMETER, SENSORTOUCHExergen Corp.2001-07-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10834098000560PackageGS11In Commercial Distribution
00834098000563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083409800056010834098000560
00834098000563008340980005638340980005630834098000563

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
617-923-9900medical@exergen.com

Regulatory Flags#

DUNS number
061266060
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00834098000181Exergen Temporal ScannerTAT-5000S-TTL124003, 124003-R2016-09-24
00834098000198Exergen Temporal ScannerTAT5000S-TTL124006, 124006-R2016-09-24
00834098000204Exergen Temporal ScannerTAT-5000S-TTL124004, 124004-R2016-09-24
00834098000211Exergen Temporal ScannerTAT-5000S-TTL124005, 124005-R2016-09-24
00834098000228Exergen Temporal ScannerTAT-5000S-USB124260, 124260-R2016-09-24
00834098000235Exergen Temporal ScannerTAT-5000S-USB124261, 124261-R2016-09-24
00834098000242Exergen Temporal ScannerTAT5000S-USB124262, 124262-R2016-09-24
00834098000259Exergen Temporal ScannerTAT-5000S-USB124263, 124263-R2016-09-24
00834098000273Exergen Temporal ScannerTAT5000S-RS232-QR124264-AF-MD2016-09-24
00834098000280Exergen Temporal ScannerTAT-5000S-CORO124001, 124001-R2016-09-24
00834098000297Exergen Temporal ScannerTAT-5000S-CORO1240022016-09-24
00834098000303Exergen Temporal ScannerTAT-5000S-CORO124010, 124010-R2016-09-24
00834098000310Exergen Temporal ScannerTAT-5000S-CORO1240112016-09-24
00834098000471Exergen Temporal ScannerTAT5000S-RS232-QR124234-AC-GN2016-09-24
00834098000495Exergen Temporal ScannerTAT-5000S-USB124231-OF-GN2018-06-14
00834098000518Exergen Temporal ScannerTAT5000S-RS232-MR124237-AF-MR2017-11-01
00834098000532Exergen Temporal ScannerTAT-5000S-232EP124229-AF-EP2021-03-29
00834098000549Exergen Temporal ScannerTAT-5000S-MUSB124269-AF-GE2023-06-21
00834098000556Exergen Temporal ScannerTAT-5000S-MUSB124269-OF-GE2023-06-21
00834098000570Exergen Temporal ScannerTAT-5000S-MUSB124269-OC-GE2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970331862711TIXMORShenzhen Ruiankang Technology Co. Ltd.FLL2026-11-05
00681131280228EquateWAL-MART STORES, INC.FLL2026-11-03
09120095900816SteadyTempSteadySense GmbHFLL2026-11-03
09120095900823SteadyTempSteadySense GmbHFLL2026-11-03
00841709121746MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONFLL2026-10-30
00860016681507UNIVERHEALTHHangzhou Universal Electronic Co.,Ltd.FLL2026-10-28
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09