FDA.reportPublic FDA data

Oto Temp Probe Covers

Primary DI
10834098000324
Brand
Oto Temp Probe Covers
Company
EXERGEN CORPORATION
Model
PCT-2500 Disposable Wraps
Catalog number
128600, 128800, 128910
Device description
Oto Temp Probe Covers Disposable Optical Film for Use on Ototemp Infrared Thermometers
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K882949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882949000TYMPANIC TEMPERATURE SCANNEROmega Medical Corp.1988-11-01FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30834098000328PackageGS110In Commercial Distribution
5083409800322PackageGS110In Commercial Distribution
10834098000324PrimaryGS10
00834098000327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3083409800032830834098000328
5083409800322050834098003225083409800322
1083409800032410834098000324
00834098000327008340980003278340980003270834098000327

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.

Contacts#

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

Regulatory Flags#

DUNS number
061266060
Device count
250
Lot or batch
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

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