FDA.reportPublic FDA data

Portal 724

Primary DI
00862492000322
Brand
Portal 724
Company
OPTUMHEALTH CARE SOLUTIONS, INC.
Model
EM724BT
Catalog number
AAA-85009
Device description
Optum Home Scale I-ICUE
Published
2020-12-07
Public version status
Update
Distribution status
Not 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
00862492000322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862492000322008624920003228624920003220862492000322

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078270206
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862492000353Avoset-Optum Homecare InfusionPump Avoset InfusionAAA-001712024-04-24
00862492000308Zyno SolutionsPump Nimbus II PlusAAA-001702020-12-07
00862492000315Portal 724EM724BT AAA-800122020-12-07
00862492000339A&DUA651BLEAAA-800132020-12-07
00862492000346A&DUA651BLEAAA-000072020-12-07
08624920003082OmronHEM9200TAAA-000062020-05-26
08624920003099CMEPump T34OBAAA-001632020-05-26
08624920003112Portal 724EM724BTAAA-800052020-05-26
08624920003129OmronHEM9200TAAA-800062020-05-26
08624920003136Portal 724EM724BTAAA-800122020-05-26
08624920003143OmronHEM9200TAAA-800132020-05-26
08624920003167Portal 724EM724BTAAA-850052020-05-26
08624920003181Portal 724EM724BTAAA-850092020-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987001125SR ScalesS R INSTRUMENTS, INC.FRI2026-06-08
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FRI2026-06-02
04719846009455CharderCHARDER ELECTRONIC CO., LTD.FRI2026-04-29
04719846017115CharderCHARDER ELECTRONIC CO., LTD.FRI2026-03-27
00810079260003Teladoc Health, Inc.Teladoc Health, Inc.FRI2026-02-17
00850068074310TenoviTenovi Co.FRI2025-11-20
00850068074389TenoviTenovi Co.FRI2025-11-20
00850068074471TenoviTenovi Co.FRI2025-11-20
04719846016699CharderCHARDER ELECTRONIC CO., LTD.FRI2025-11-13
00850033352191Dario Smart Scale (Cellular)- Wight Management SystemDARIOHEALTH CORP.FRI2025-10-15
00810079260010Teladoc Health, Inc.Teladoc Health, Inc.FRI2025-09-22
00845717011785R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-08
00845717011068R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-02
00845717011938R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-02
00845717012102TrackstarVERIDIAN HEALTHCARE LLCFRI2025-09-02
00845717012195TrackstarVERIDIAN HEALTHCARE LLCFRI2025-09-02
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
04012030022668seca 274seca GmbH & Co. KGFRI2025-06-02
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