OPTUMHEALTH CARE SOLUTIONS, INC.

Address:877 Franklin Rd,Marietta,GA,30067,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SCALE, STAND-ON, PATIENT (FRI) (2) System, measurement, blood-pressure, non-invasive (DXN) (2) Pump, infusion (FRN) (1)

Premarket Exempt

Yes

Clear

Zyno Solutions - 00862492000308 Catalog Number : AAA-00170

Device Description : Nimbus II-Optum Homecare Infusion

Device Class : 2

Duns Number: 078270206

Premarket Exempt : Yes

Product Code : FRN

Prescription Use : No

Device Count : 1

Portal 724 - 00862492000315 Catalog Number : AAA-80012

Device Description : Optum Home Scale I-Apollo

Device Class : 1

Duns Number: 078270206

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

Portal 724 - 00862492000322 Catalog Number : AAA-85009

Device Description : Optum Home Scale I-ICUE

Device Class : 1

Duns Number: 078270206

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

A&D - 00862492000339 Catalog Number : AAA-80013

Device Description : Optum Home BP I-Apollo

Device Class : 2

Duns Number: 078270206

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

A&D - 00862492000346 Catalog Number : AAA-00007

Device Description : Optum Homecare Portal W/BP

Device Class : 2

Duns Number: 078270206

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

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