FDA.reportPublic FDA data

Tecnimed - Handi-Craft Company

Primary DI
00182097000238
Brand
Tecnimed - Handi-Craft Company
Company
TECNIMED SRL
Model
VisioFocus SMART
Catalog number
06470
Device description
Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: forehead (without contact).
Published
2017-06-27
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00182097000245PackageGS16Not in Commercial Distribution
00182097000238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00182097000245001820970002451820970002450182097000245
00182097000238001820970002381820970002380182097000238

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature-18 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
445878788
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00182097000177Tecnimed - BV MedicalVisioFocus 06400064002017-03-10
00182097000689Tecnimed - HammacherVisioFocus064002021-01-20
00182097000696Tecnimed - HammacherVisioFocus064002021-01-20
00182097000078Tecnimed - BV MedicalThermofocus 08000800H52016-09-12
00182097000559TECNIMED - Medline Industries, IncVisioFocus PRO 06480064802020-08-11
00182097000511Tecnimed VisioFocus PRO 06480064802020-06-04
00182097000474Tecnimed - BV MedicalVisioFocus PRO 06480064802020-04-13
00182097000498TECNIMED - Hopkins Medical ProductsVisioFocus PRO 06480064802020-04-13
00182097000429Tecnimed - 3J MEDICAL SUPPLIES IncVisioFocus MINI067002019-09-10
00182097000436Tecnimed - 3J MEDICAL SUPPLIES IncVisioFocus064002019-09-10
00182097000443Tecnimed - 3J MEDICAL SUPPLIES IncVisioFocus PRO064802019-09-10
00182097000054Tecnimed - BV MedicalThermofocus 07000700A22016-09-12
00182097000061Tecnimed - BV MedicalThermofocus 0150001500A32016-09-12
00182097000139Hopkins Medical ProductsTouch-Free ThermometerThermofocus 01500A32016-09-20
00182097000153TECNIMED - Hopkins Medical ProductsVisioFocus 06400064002017-02-17
00182097000191Tecnimed - Constant Care TechnologyThermofocus 08002017-03-30
00182097000351TecnimedVisioFocus MINI067002018-07-30
00182097000368TECNIMEDDisc-o-Click2018-05-15
00182097000023TecnibrandsClick2017-08-02
00182097000382TECNIMEDDisc-o-Click2018-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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