FDA.report

KINLee Non-contact Electronic Forehead Infrared Thermomter

Primary DI
06973337423016
Brand
KINLee Non-contact Electronic Forehead Infrared Thermomter
Company
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
Model
FT3010
Published
2021-02-02
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

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K201582000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K201582000Non-contact Electronic Forehead Infrared ThermometerZhongshan Jinli Electronic Weighing  Equipment Co., Ltd.2021-01-15FLL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06973337423016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973337423016069733374230166973337423016

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
654691633
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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