| Primary Device ID | 20811505030072 |
| NIH Device Record Key | e5653124-4ec3-4f42-ab72-54f0480ef178 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ivenix, Inc. |
| Version Model Number | SET-0019-1 |
| Catalog Number | SET-0019-1 |
| 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 | 00811505030078 [Primary] |
| GS1 | 20811505030072 [Package] Contains: 00811505030078 Package: Shipper [25 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
| 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 |