FDA.reportPublic FDA data

Exergen Temporal Scanner

Primary DI
10834098000577
Brand
Exergen Temporal Scanner
Company
EXERGEN CORPORATION
Model
TAT-5000S-RS232-MUSB
Catalog number
124269-OC-GE
Device description
TAT-5000S-RS232-MUSB Oral Calibration - Celcius
Published
2023-06-21
Public version status
New
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
10834098000577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1083409800057710834098000577

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
10834098000904Disposable Caps1342031342032023-06-13
00834098000907Disposable Caps1342031342032023-06-13
00834098003021Exergen Temporal ScannerTAT2000C Smart Glow1401102023-04-11
00834098002956Exergen Temporal ScannerTAT2000C Smart Glow140072, 144072, 140075, 144075, 1401002019-09-23

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