FDA.reportPublic FDA data

Infrared Thermometer

Primary DI
00840061482809
Brand
Infrared Thermometer
Company
Shenzhen Pacom Medical Instruments Co., Ltd.
Model
PC828
Device description
Model: PC828;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
K172889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172889000Infrared ThermometerShenzhen Pacom Medical Instruments Co., Ltd.2018-05-25FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840061482806PackageGS150In Commercial Distribution
00840061482809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084006148280610840061482806
00840061482809008400614828098400614828090840061482809

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.

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
00840061480904Infrared ThermometerPC8092020-04-15
10840061481601Infrared ThermometerPC8162021-05-01
00840061482830BionsoPC8282021-05-01
10840061482837BionsoPC8282021-05-01
00840061482908Infrared ThermometerPC8292021-04-17
10840061482905Infrared ThermometerPC8292021-04-17
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