FDA.reportPublic FDA data

Disposable Caps

Primary DI
00834098000907
Brand
Disposable Caps
Company
EXERGEN CORPORATION
Model
134203
Catalog number
134203
Device description
Disposable Caps Covers Probe, Box of 1000 for Exergen Temporal Scanner Thermometer
Published
2023-06-13
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
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
10834098000904PrimaryGS10
00834098000907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083409800090410834098000904
00834098000907008340980009078340980009070834098000907

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
Special Storage Condition, Specify00Keep Dry
Storage Environment Humidity0 Percent (%) Relative Humidity33 Percent (%) Relative Humidity
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
1000
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
00834098003021Exergen Temporal ScannerTAT2000C Smart Glow1401102023-04-11
00834098002956Exergen Temporal ScannerTAT2000C Smart Glow140072, 144072, 140075, 144075, 1401002019-09-23

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