Ivenix Infusion System SET-0032-01
GUDID 10811505030211
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1)
IVENIX, INC.
Electric infusion pump administration set, single-use| Primary Device ID | 10811505030211 |
| NIH Device Record Key | e80371e1-d0b2-46f5-bd5d-cd9f0fe355a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ivenix Infusion System |
| Version Model Number | SET-0032-01 |
| Catalog Number | SET-0032-01 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811505030214 [Primary] |
| GS1 | 10811505030211 [Package] Contains: 00811505030214 Package: Shipper [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183311
FDA Product Code
| FPA | Set, Administration, Intravascular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-01 |
| Device Publish Date | 2022-03-24 |
On-Brand Devices [Ivenix Infusion System]
| 00811505030184 | Large Volume Pump (LVP) Software (order 1 per pump), Version 3.0.0 |
| 00811505030177 | Infusion Management System (IMS) Version 3.0.0 |
| 10811505030235 | LVP Primary Administration Set, Single-Inlet, Low-Sorbing, Microbore (Qty 1) |
| 10811505030228 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, Microbor |
| 10811505030211 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1) |
| 00811505030351 | Infusion Management System (IMS), version 4.0.0 |
| 00811505030344 | Large Volume Pump (LVP) Software (order 1 per pump), version 5.0.0 |
| 00811505030320 | Large Volume Pump (LVP) |
| 00811050530399 | Infusion Management System (IMS) |
| 00811050530375 | Large Volume Pump (LVP) Software (order 1 per pump) |
| 00811505030399 | Infusion Management System (IMS) |
| 00811505030375 | Large Volume Pump (LVP) Software (order 1 per pump) |
| 00811505030443 | Infusion Management System (IMS) |
| 00811505030436 | Large Volume Pump (LVP) Software (order 1 per pump) |
Trademark Results [Ivenix Infusion System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IVENIX INFUSION SYSTEM 97612170 not registered Live/Pending |
Fresenius Kabi USA, LLC 2022-09-29 |
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