FDA.reportPublic FDA data

Andnesfit Health

Primary DI
04897100310131
Brand
Andnesfit Health
Company
ANDESFIT LIMITED
Model
ADF-B38A
Device description
Wireless Non-Contact Infrared Body/Surface Thermometer
Published
2022-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04897100310131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897100310131048971003101314897100310131

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
664101036
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897100310025Andnesfit HealthADF-B062021-05-03
04897100310162Andnesfit HealthADF-MSA1002021-05-03
00146191010005AndesfitADF-MSA1002019-09-09
04897100310254Andesfit ADF-B612023-05-02
04897100310056Andnesfit HealthADF-B192022-02-08
04897100310117Andnesfit HealthADF-34A2022-02-08
04897100310018Andnesfit HealthADF-B052021-03-12
00146191200505Andnesfit HealthADF-B052019-12-11
00146191200604AndesfitADF-B062019-05-09
04897100310155Andnesfit HealthADF-B885T2021-08-18
04897100310070Andnesfit HealthADF-B272021-05-03
00146191203803AndesfitADF-B38A2019-03-15
00146191203407Andnesfit HealthADF-B34A2020-05-29
00146191201908AndesfitADF-B192019-03-15
00146191210221AndesfitADF-B102W2019-03-15
00146191202707Andnesfit HealthADF-B272019-10-14
00146191202776Andnesfit HealthADF-B27GTS2019-10-14
00146191288527Andnesfit HealthADF-B885T2019-10-14

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