Portal 724

Primary DI
08624920003167
Brand
Portal 724
Company
OPTUMHEALTH CARE SOLUTIONS, INC.
Model
EM724BT
Catalog number
AAA-85005
Device description
Optum Home Scale II-ICUE
Published
2020-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08624920003167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08624920003167086249200031678624920003167

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
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00862492000353Avoset-Optum Homecare InfusionPump Avoset InfusionAAA-001712024-04-24
00862492000308Zyno SolutionsPump Nimbus II PlusAAA-001702020-12-07
00862492000315Portal 724EM724BT AAA-800122020-12-07
00862492000322Portal 724EM724BTAAA-850092020-12-07
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
08624920003181Portal 724EM724BTAAA-850092020-05-26