IVX Fluid Transfer Set
Omnicell, Inc.
Omnicell S.R.L.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006153342 | 3006153342 | Omnicell S.R.L. | 1 | N | 2026-01-01 | Piazzale Legnami 1/b Edificio 9 Comprensorio Gaslini TRIESTE IT 34145 |
| 3007880912 | 3007880912 | OMNICELL, INC. | 1 | N | 2026-01-01 | 500 Cranberry Woods Dr. Suite 400 Cranberry Township PA US 16066 |
| 3011278888 | 3011278888 | OMNICELL, INC. | 1 | N | 2026-01-01 | 51 Pennwood Place Warrendale PA US 15086 |
| 3015426639 | 3015426639 | OMNICELL, INC. | 1 | N | 2026-01-01 | 725 Sycamore Drive Milpitas CA US 95035 |
| 3015425093 | 3015425093 | OMNICELL, INC. | 1 | N | 2020-04-25 | 590 East Middlefield Road Mountain View CA US 94043 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 237315 | 1574311760 | K212530 | IVX Fluid Transfer Set | LHI | 2022-04-24 |
| 227395 | 1461586989 | ||||
| 237316 | 1461586989 | ||||
| 227394 | 1461586989 | ||||
| 237315 | 1461586989 | ||||
| 237315 | 1496909443 | ||||
| 237316 | 1496909443 | ||||
| 67078 | 2072842515 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LHI | 1 | 2022-04-24 |
PMN#
GUDID#
IVX Station Reconstitution Transfer Set - The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source for use in the preparation of final compounded drugs for patient infusion administration.
2025-01-23
IVX Manager - The IVX Manager (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking orders (requests) for preparations, reviewing device requests assigned for compounding, customizing workflows and protocols for the IV Solutions products. The IVX Manager is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.
2024-05-10
IVX Cloud - The IVX Cloud (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking orders (requests) for preparations, reviewing device requests assigned for compounding, customizing workflows and protocols for the IV Solutions products. The IVX Cloud is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.
2024-01-10
IVX Cloud - The IVX Cloud is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.
2021-06-25
IVX Station Stock Solution Transfer Set - The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
2023-06-06
IVX Station Stock Solution Transfer Set - The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
2023-06-06
XT Anesthesia Workstation (AWS) - The Omnicell XT Anesthesia Workstation (AWS) is an automated dispensing system intended for securing and managing medications used by anesthesia providers and pharmacy staff.
2021-02-15
IVX Station - The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting of Non-hazardous drugs and diluents, or, Hazardous drugs compounded in non-hazardous Primary Engineering Controls (PECs) as a result of site-specific hazard risk analysis, to be used for intravenous administration.
2021-02-08