IVENIX, INC.

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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

Pump, Infusion (FRN) (3) Set, Administration, Intravascular (FPA) (3) Infusion Safety Management Software (PHC) (1)

Premarket Exempt

Clear

Ivenix Infusion System - 00811505030184 Catalog Number : LVP-SW-0002

Device Description : Large Volume Pump (LVP) Software (order 1 per pump), Version 3.0.0

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030214 Catalog Number : SET-0032-01

Device Description : LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1)

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030221 Catalog Number : SET-0033-01

Device Description : LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, Microbore (Qty 1)

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030238 Catalog Number : SET-0034-01

Device Description : LVP Primary Administration Set, Single-Inlet, Low-Sorbing, Microbore (Qty 1)

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030320 Catalog Number : LVP-0004

Device Description : Large Volume Pump (LVP)

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030344 Catalog Number : LVP-SW-0004

Device Description : Large Volume Pump (LVP) Software (order 1 per pump), version 5.0.0

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030351 Catalog Number : IMS-0700

Device Description : Infusion Management System (IMS), version 4.0.0

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : PHC

Prescription Use : Yes

Device Count : 1

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