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

Set, Administration, Intravascular (FPA) (5) Pump, Infusion (FRN) (3) Infusion Safety Management Software (PHC) (2)

Premarket Exempt

Clear

Ivenix Inc. - 00811505030009 Catalog Number : LVP-0003

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, Inc. - 00811505030016 Catalog Number : IMS-0500

Device Description : Infusion Management System (IMS), version 2.0

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : PHC

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030023 Catalog Number : BKT-0004

Device Description : LVP Charging Bracket

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030030 Catalog Number : SET-0014-1

Device Description : LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Fil LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 1)

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030054 Catalog Number : SET-0013-1

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

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030078 Catalog Number : SET-0019-1

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

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030108 Catalog Number : SET-0021-1

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

Device Class :

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030122 Catalog Number : LVP-SW-0001

Device Description : Large Volume Pump (LVP) Software (order 1 per pump), version 2.0

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Ivenix, Inc. - 00811505030153 Catalog Number : SET-0016-1

Device Description : LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, Luer Conn LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, Luer Connector (Qty 1)

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

Ivenix Infusion System - 00811505030177 Catalog Number : IMS-0600

Device Description : Infusion Management System (IMS) Version 3.0.0

Device Class : 2

Duns Number: 939332289

Premarket Exempt : No

Product Code : PHC

Prescription Use : Yes

Device Count : 1

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