FDA.reportPublic FDA data

Alcedo

Primary DI
00856471007174
Brand
Alcedo
Company
NATURE MAJOR INC
Model
AE171
Device description
AE171 Digital Thermometer is a forehead and ear temperature measurement device
Published
2019-10-22
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172795000Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd.2018-03-14FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856471007171PackageGS1100In Commercial Distribution
00856471007174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085647100717110856471007171
00856471007174008564710071748564710071740856471007174

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
114908257
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856471007112AlcedoAE1702019-06-24
00856471007211AlcedoAE1752020-06-23
00856471007266AlcedoAE1802021-11-04
00856471007280AlcedoAE1822021-11-04
00856471007303AlcedoAE1832021-11-04
00856471007235AlcedoAE1772020-07-30
00856471007310AlcedoB212021-11-04
00856471007327AlcedoAE1762021-11-04
10856471007263AlcedoAE1802021-11-04
10856471007287AlcedoAE1822021-11-04
10856471007300AlcedoAE1832021-11-04
10856471007317AlcedoB212021-11-04
10856471007324AlcedoAE1762021-11-04
00856471007204AlcedoAE1742020-04-06
20856471007239AlcedoAE1772020-07-30
10856471007218AlcedoAE1752020-06-23
10856471007201AlcedoAE1742020-04-06
00856471007082AlcedoAE1692019-07-16
00856471007099AlcedoB212019-04-09
10856471007089AlcedoAE1692019-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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