FDA.reportPublic FDA data

Exergen Temporal Scanner

Primary DI
50834098002920
Brand
Exergen Temporal Scanner
Company
EXERGEN CORPORATION
Model
TAT2000C
Catalog number
140055, 144052
Device description
TAT2000C Temporal Scanner
Published
2018-05-25
Public version status
New
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
30834098002926PackageGS112In Commercial Distribution
50834098002920PackageGS148In Commercial Distribution
00834098002925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3083409800292630834098002926
5083409800292050834098002920
00834098002925008340980029258340980029250834098002925

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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

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