Pinnacle®
Final Assy, Control Module, TPN Manager
2manufacturers in China registered for this device type
13catalogue numbers in this listing
3recalls 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 | B. Braun 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2025-02-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Special storage condition: Fragile, handle with care |
| Distribution end date | 2023-03-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 601184-99 | In distribution | |
| PC1000 | In distribution | |
| 601231-99 | In distribution | |
| 601231 | In distribution | |
| 601192-99 | In distribution | |
| 601234 | In distribution | |
| PC1000-99 | In distribution | |
| 601233 | In distribution | |
| 601184 | In distribution | |
| 601235 | In distribution | |
| 601212-99 | Withdrawn | |
| 601212 | Withdrawn | |
| 601192 | Withdrawn |
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 |
| System/Device, Pharmacy Compounding | Baxter Healthcare Corporation | 9 |
| DianaTM Compounding Workflow System | ICU Medical, Inc | 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
3 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 |
|---|---|---|---|---|---|
| 2020-11-23 | Class II | Software change control | There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that | 248 units | 2023-03-14 |
| 2020-11-23 | Class II | Software change control | There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that | 16 units | 2023-03-14 |
| 2020-11-23 | Class II | Software change control | There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that | 85 units | 2023-03-14 |
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.