FDA.reportPublic FDA data

Tecnimed - Hammacher

Primary DI
00182097000696
Brand
Tecnimed - Hammacher
Company
TECNIMED SRL
Model
VisioFocus
Catalog number
06400
Device description
Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages
Published
2021-01-20
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

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
K122412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122412000VISIOFOCUSTecnimed S.R.L.2013-03-13FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00182097000696PackageGS190In Commercial Distribution
00182097000689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00182097000696001820970006961820970006960182097000696
00182097000689001820970006891820970006890182097000689

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
445878788
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00182097000177Tecnimed - BV MedicalVisioFocus 06400064002017-03-10
00182097000238Tecnimed - Handi-Craft CompanyVisioFocus SMART064702017-06-27
00182097000689Tecnimed - 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

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22