FDA UDI
In Commercial Distribution
🇺🇸 United States
IVX Manager
DI: 00860006285043
·
Model: IVX Manager
·
Omnicell, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IVX Manager
- Primary DI
- 00860006285043
- Version / Model
- IVX Manager
- Company Name
- Omnicell, Inc.
- Labeler DUNS
- 080720061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-10
- Public Version
- 1
- Public Version Date
- 2024-05-20
- Public Version Status
- New
- Public Device Record Key
- 51a1b268-931e-469a-aada-4dfc96f57be8
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEP | System/Device, Pharmacy Compounding | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17459 | Intravenous solution compounder | A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006285043 | GS1 |