DianaTM Compounding Workflow System
Diana Workflow Management Software
2manufacturers in China registered for this device type
9catalogue numbers in this listing
6recalls on this code
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | NEP |
| Device type | System/Device, Pharmacy Compounding |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Handling Environment Temperature; Storage environment temperature 0 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS2800-04-01 | In distribution | |
| DS2000-04-01 | In distribution | |
| DS2130-04-01 | In distribution | |
| DS2810-04-01 | In distribution | |
| DS2110-04-01 | In distribution | |
| DS2900-04-01 | In distribution | |
| DS2100-04-01 | In distribution | |
| DS2010-04-01 | In distribution | |
| DS2120-04-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exactamix | Baxter Healthcare Corporation | 27 |
| ICU Medical, Inc. | ICU Medical, Inc | 16 |
| Apex™ | B. Braun Medical Inc. | 15 |
| Pinnacle® | B. Braun Medical Inc. | 13 |
| System/Device, Pharmacy Compounding | Baxter Healthcare Corporation | 9 |
| Repeater | Baxter Healthcare Corporation | 8 |
| DianaTM Automated Drug Compounding System | ICU Medical, Inc | 5 |
| Single Lead High Volume Pump Chamber SET | MPS Pharma & Medical, Inc. | 4 |
| Abacus | Baxter Healthcare Corporation | 4 |
| Apoteca | AEA SRL | 3 |
| GRI-BAG | Laboratorios Grifols SA | 3 |
| Exactamix | Baxter Corporation Englewood | 3 |
Showing 12 of 35. All products under System/Device, Pharmacy Compounding
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-03-08 | Class II | Use error | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. | 57 units | 2016-08-17 |
| 2016-03-08 | Class II | Use error | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. | 49 units | 2016-08-17 |
| 2016-03-08 | Class II | Use error | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. | 47 units | 2016-08-17 |
| 2016-03-08 | Class II | Use error | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. | 3 units | 2016-08-17 |
| 2016-03-08 | Class II | Use error | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. | 36 units | 2016-08-17 |
| 2016-03-08 | Class II | Use error | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. | 4 units | 2016-08-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.