FDA.reportPublic FDA data

Infrared Thermometer

Primary DI
00840061480904
Brand
Infrared Thermometer
Company
Shenzhen Pacom Medical Instruments Co., Ltd.
Model
PC809
Device description
Model: PC809;Brand: None.
Published
2020-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K190717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190717000Infrared Thermometer, model: PC808Shenzhen Pacom Medical Instruments Co., Ltd.2019-12-13FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840061480901PackageGS1100In Commercial Distribution
00840061480904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084006148090110840061480901
00840061480904008400614809048400614809040840061480904

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, ear/skinA hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421356348
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840061486807Infrared ThermometerPC8682020-04-15
00840061480119FLTRPC8012020-09-26
00840061481604Infrared ThermometerPC8162021-05-01
10840061481601Infrared ThermometerPC8162021-05-01
00840061482830BionsoPC8282021-05-01
10840061482837BionsoPC8282021-05-01
00840061482908Infrared ThermometerPC8292021-04-17
10840061482905Infrared ThermometerPC8292021-04-17
00840061482809Infrared ThermometerPC8282020-04-15
00840061482816FLTRPC8282020-08-17
00840061486814FLTRPC8682020-05-25
00840061486821FLTRPC8682020-07-17
00840061482823FLTRPC8282020-08-17
10840061480116FLTRPC8012020-09-26
10840061482813FLTRPC8282020-08-17
10840061486828FLTRPC8682020-07-17
10840061486811FLTRPC8682020-05-25
00840061480911CarounePC8092019-10-31
10840061482806Infrared ThermometerPC8282020-04-15
10840061486804Infrared ThermometerPC8682020-04-15

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Primary DI, Brand, Company table
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22