FDA.reportPublic FDA data

Infrared Thermometer

Primary DI
06948423808763
Brand
Infrared Thermometer
Company
Shenzhen Pango Electronic Co., Ltd.
Model
PG-IRT1603
Published
2020-04-17
Public version status
New
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
K182597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182597000Infrared thermometerShenzhen Pango Electronic Co., Ltd.2019-04-03FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948423808763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948423808763069484238087636948423808763

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
529222127
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948423808817Infrared ThermometerPG-IRT16012020-04-17
06948423808824Infrared ThermometerPG-IRT16022020-04-17
06948423800002Electronic Blood Pressure MonitorPG-800B2016-11-23
06948423800019Electronic Blood Pressure MonitorPG-800BD2016-11-23
06948423800026Electronic Blood Pressure MonitorPG-800B-12016-11-23
06948423800033Electronic Blood Pressure MonitorPG-800BD-12016-11-23
06948423800040Electronic Blood Pressure MonitorPG-800B32016-11-23
06948423800057Electronic Blood Pressure MonitorPG-800B42016-11-23
06948423800064Electronic Blood Pressure MonitorPG-800B4D2016-11-23
06948423800071Electronic Blood Pressure MonitorPG-800B52016-11-23
06948423800088Electronic Blood Pressure MonitorPG-800B5-12016-11-23
06948423800095Electronic Blood Pressure MonitorPG-800B62016-11-23
06948423800101Electronic Blood Pressure MonitorPG-800B6D2016-11-23
06948423800118Electronic Blood Pressure MonitorPG-800B6-12016-11-23
06948423800125Electronic Blood Pressure MonitorPG-800B6-22016-11-23
06948423800132Electronic Blood Pressure MonitorPG-800B72016-11-23
06948423800149Electronic Blood Pressure MonitorPG-800B82016-11-23
06948423800156Electronic Blood Pressure MonitorPG-800B92016-11-23
06948423800163Electronic Blood Pressure MonitorPG-800B102016-11-23
06948423800170Electronic Blood Pressure MonitorPG-800B112016-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325297FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325310FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325389FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870335265FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22