FDA.reportPublic FDA data

Exergen Temporal Scanner

Primary DI
10834098000133
Brand
Exergen Temporal Scanner
Company
EXERGEN CORPORATION
Model
TAT5000 Quick Release
Catalog number
124282, 124287, 124291, 124295, 124278, 124282-R,
Device description
TAT5000 Quick Release Oral Calibration
Published
2016-09-24
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
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
10834098000133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083409800013310834098000133

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
061266060
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10834098000850Exergen Temporal ScannerTAT-5000S124275S, 124276S, 124275S-R, 124276S-R2023-10-11
10834098000478Exergen Temporal ScannerTAT5000S-RS232-QR124257, 124225-AC-GN, 124234-AC-GN, 124234-AF-GN, 2016-09-24
00834098002925Exergen Temporal ScannerTAT2000C140055, 1440522018-05-25
00834098002918Exergen Temporal ScannerTAT2000C Original140050, 144060, 1400332016-09-24
10834098000966Exergen Thermographic ScannerDT-5000S-USB1241852024-01-02
10834098000973Exergen Temporal ScannerTAT-5000S1244202023-10-18
10834098000867Exergen Temporal ScannerTAT-5000S124374S, 124375S, 124375S-R2023-10-11
10834098000607Exergen Temporal ScannerTAT-5000S-USB-GE2124227-AF-GE2023-10-11
10834098000614Exergen Temporal ScannerTAT-5000S-USB-GE2124227-OC-GE2023-10-11
10834098000621Exergen Temporal ScannerTAT-5000S-USB-GE2124227-OF-GE2023-10-11
10834098000874Exergen Temporal ScannerTAT-5000S124277S, 124286S, 124288S, 124290S, 124292S, 124292023-10-11
10834098000881Exergen Temporal ScannerTAT-5000S124278S, 124287S, 124289S, 124291S, 124293S, 124292023-10-11
10834098000591Exergen Temporal ScannerTAT-5000S-USB-GE2124227-AC-GE2023-04-11
10834098000546Exergen Temporal ScannerTAT-5000S-RS232-MUSB124269-AF-GE2023-06-21
10834098000553Exergen Temporal ScannerTAT-5000S-RS232-MUSB124269-OF-GE2023-06-21
10834098000560Exergen Temporal ScannerTAT-5000S-RS232-MUSB124269-AC-GE2023-06-21
10834098000577Exergen Temporal ScannerTAT-5000S-RS232-MUSB124269-OC-GE2023-06-21
10834098000904Disposable Caps1342031342032023-06-13
00834098000907Disposable Caps1342031342032023-06-13
00834098003021Exergen Temporal ScannerTAT2000C Smart Glow1401102023-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325297FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325310FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325389FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870335265FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870357830FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870368867FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870368874FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22