Ivenix, Inc. SET-0016-1

GUDID 20811505030157

Electric infusion pump administration set, single-use

Primary Device ID	20811505030157
NIH Device Record Key	3ae9e157-eb05-4c55-b181-737fb3ac7e54
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ivenix, Inc.
Version Model Number	SET-0016-1
Catalog Number	SET-0016-1
Company DUNS	939332289
Company Name	IVENIX, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00811505030153 [Primary]
GS1	20811505030157 [Package] Contains: 00811505030153 Package: Shipper [25 Units] In Commercial Distribution

FPA	Set, Administration, Intravascular

Steralize Prior To Use	false
Device Is Sterile	true

20811505030157	LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, Luer Connector (Qty 1)
00811505030122	Large Volume Pump (LVP) Software (order 1 per pump), version 2.0
00811505030108	LVP Primary Administration Set, Single-Inlet, Low-Sorbing (Qty 1)
20811505030072	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, Microbore (Qt
20811505030058	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 1)
20811505030034	LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 1)
00811505030023	LVP Charging Bracket
00811505030016	Infusion Management System (IMS), version 2.0