FDA.reportPublic FDA data

1BYONE

Primary DI
00863696000347
Brand
1BYONE
Company
1BYONEPRODUCTS INC.
Model
JPD-FR401
Device description
Infrared Thermometer
Published
2016-11-10
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863696000354PackageGS11In Commercial Distribution
10863696000351PackageGS1100In Commercial Distribution
00863696000347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863696000354008636960003548636960003540863696000354
1086369600035110863696000351
00863696000347008636960003478636960003470863696000347

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
845019202
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008580690070091BYONE725EU-00032017-05-24
008580690070161BYONE725EU-00022017-05-24
008636960003611BYONEPL-029K8(725EU-0001)2017-05-24
008636960003231BYONEJPD-500D2016-11-10
008580690070541byoneNT172018-04-12
008580690072071 BY ONE703NA-00052020-06-29
008580690072211 BY ONE703NA-00052020-06-29
008580690071531 BY ONE9-JK14US062020-06-08
008580690071841 BY ONE9-JK14US052020-06-08
008580690070301BYONETMB-1585-BT2017-08-28
008580690070611byonePL-029K16B2019-12-12
008580690070851byonePL-029K16B-P32019-12-14
008500142610161BYONETMB-1585-BS2019-11-11
008636960003091BYONETMB-15852016-10-19

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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