Ivenix SET-0030-1
GUDID 00811505030160
LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1)
IVENIX, INC.
Electric infusion pump administration set, single-use| Primary Device ID | 00811505030160 |
| NIH Device Record Key | d097bbfa-8792-4eec-8031-3c120399641b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ivenix |
| Version Model Number | SET-0030-1 |
| Catalog Number | SET-0030-1 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811505030160 [Primary] |
| GS1 | 10811505030167 [Package] Package: Shipper [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213089
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 | 2023-05-12 |
| Device Publish Date | 2023-05-04 |
Devices Manufactured by IVENIX, INC.
| 00811505030436 - Ivenix Infusion System | 2023-08-15 Large Volume Pump (LVP) Software (order 1 per pump) |
| 00811505030443 - Ivenix Infusion System | 2023-08-15 Infusion Management System (IMS) |
| 00811505030375 - Ivenix Infusion System | 2023-07-27 Large Volume Pump (LVP) Software (order 1 per pump) |
| 00811505030399 - Ivenix Infusion System | 2023-07-27 Infusion Management System (IMS) |
| 00811505030160 - Ivenix | 2023-05-12LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1) |
| 00811505030160 - Ivenix | 2023-05-12 LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1) |
| 00811050530375 - Ivenix Infusion System | 2023-04-17 Large Volume Pump (LVP) Software (order 1 per pump) |
| 00811050530399 - Ivenix Infusion System | 2023-04-17 Infusion Management System (IMS) |
| 00811505030320 - Ivenix Infusion System | 2022-09-15 Large Volume Pump (LVP) |
Trademark Results [Ivenix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IVENIX 88873496 not registered Live/Pending |
Ivenix, Inc. 2020-04-15 |
 IVENIX 87204201 not registered Live/Pending |
Ivenix, Inc. 2016-10-14 |
 IVENIX 87204199 not registered Live/Pending |
Ivenix, Inc. 2016-10-14 |
 IVENIX 86232442 not registered Dead/Abandoned |
IVENIX, INC. 2014-03-26 |
 IVENIX 86232441 not registered Dead/Abandoned |
IVENIX, INC. 2014-03-26 |
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