FDA.reportPublic FDA data

Alcedo

Primary DI
10856471007171
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
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, battery-powered, electronic 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
114908257
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
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
00856471007174AlcedoAE1712019-10-22
20856471007239AlcedoAE1772020-07-30
10856471007218AlcedoAE1752020-06-23
10856471007201AlcedoAE1742020-04-06
00856471007082AlcedoAE1692019-07-16
00856471007099AlcedoB212019-04-09

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Primary DI, Brand, Company table
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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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22