A&D AAA-00007

GUDID 00862492000346

Optum Homecare Portal W/BP

OPTUMHEALTH CARE SOLUTIONS, INC.

Self-care monitoring/reporting software
Primary Device ID00862492000346
NIH Device Record Key1f69b888-5fc6-42e9-a7b1-4e3a2a5fa2a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameA&D
Version Model NumberUA651BLE
Catalog NumberAAA-00007
Company DUNS078270206
Company NameOPTUMHEALTH CARE SOLUTIONS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100862492000346 [Primary]

FDA Product Code

DXNSystem, measurement, blood-pressure, non-invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-15
Device Publish Date2020-12-07

On-Brand Devices [A&D]

00862492000346Optum Homecare Portal W/BP
00862492000339Optum Home BP I-Apollo

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