FDA.reportPublic FDA data

Quick Temp Infrared Thermometer

Primary DI
00850632007591
Brand
Quick Temp Infrared Thermometer
Company
HOME AIDE DIAGNOSTICS, INC.
Model
CK-T1501
Device description
Infrared Thermometer
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K193253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193253000Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd.2020-06-17FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850632007598PackageGS150In Commercial Distribution
00850632007591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200759810850632007598
00850632007591008506320075918506320075910850632007591

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-195-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Lot or batch
true
Manufacturing date on label
true

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