FDA.reportPublic FDA data

Medisante

Primary DI
04719878870016
Brand
Medisante
Company
EBM TECHNOLOGIES INCORPORATED
Model
BC800 3G
Device description
BC800 3G Weight Scale is a digital monitor for home/domestic use which measures weight.
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719878870013PackageGS15In Commercial Distribution
04719878870016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987887001314719878870013
04719878870016047198788700164719878870016

GMDN Terms#

Term, Definition table
TermDefinition
Scale weightA countermeasure that is produced in an exact unit of weight and intended to balance the weight of an object, typically on a mechanical scale, to produce a quantified measurement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657261272
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878870009EBMUNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.02026-03-10
04719878870108EBMUNISIGHT SYSTEM WITH UNIGATE2026-03-10
04719878870122EBMUNIWEB2026-03-10
04719878870191EBMEBM IDO VIEWER2026-03-10
04719878870276EBMUNIWEB 8.02026-03-10
04719878870290EBMEBM IDO VIEWER 1.2.12026-03-10
04719878879910EBMSoliPACS™ Server2023-06-09
04719878879927EBMSoliPACS™ Web Viewer ,version 5.02023-06-09
04719878879934EBMSoliPACS™ Client Viewer, version 4.02023-06-09
04719878879941EBMSoliPACS™ Client Viewer with SoliPACS™ Gateway2023-06-09
04719878879958EBMEBM VS 10002023-06-09
04719878879965EBMMobiPACS™ App2023-06-09
04719878879972EBMSoliPACS™ Web Viewer ,version 8.02023-06-09
04719878879989EBM"MobiPACS"" App 1.2.1, Rad@"2023-06-09
04719878879996EBMUniWeb 3602023-06-09

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Primary DI, Brand, Company table
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00850068074389TenoviTenovi Co.FRI2025-11-20
00850068074471TenoviTenovi Co.FRI2025-11-20
04719846016699CharderCHARDER ELECTRONIC CO., LTD.FRI2025-11-13
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00810079260010Teladoc Health, Inc.Teladoc Health, Inc.FRI2025-09-22
00845717011785R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-08
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04012030022774seca 286seca GmbH & Co. KGFRI2025-08-08
04012030022682seca 284seca GmbH & Co. KGFRI2025-08-07
04012030022699seca 284seca GmbH & Co. KGFRI2025-08-07
04012030022705seca 284seca GmbH & Co. KGFRI2025-08-07
00860013816506Empo FootprintEmpo Health, Inc.FRI2025-07-31
06970729040202CADENCEZhongshan Transtek Electronics Co.,LtdFRI2025-07-21
04012030022637seca 264seca GmbH & Co. KGFRI2025-06-02
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B726BT007A0BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007B0BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007A1BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007B1BodyTraceBODYTRACE, INCFRI2025-03-14
06970729040080TeleRPM™Zhongshan Transtek Electronics Co.,LtdFRI2025-02-06
00850070979108FondCircleFondCircle Inc.FRI2025-01-14
00093764604140A&D MedicalA&D COMPANY, LIMITEDFRI2024-10-18