Perfusor®
Perfusor® Space® Syringe Pump, Non-Wireless
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Dongguan Motormillions Industries Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 1 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd. | Shanghai | Shanghai | Exporter | 9 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | LZH |
| Device type | Pump, Infusion, Enteral |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-10-07 |
| Record revised | 2024-01-17 (version 14) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Keep dry; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 90 % RH; Special storage condition: Fragile, handle with care; Handling environment temperature 5 to 40 °C; Special storage condition: Keep away from sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8713031U | In distribution | |
| 8713032U | In distribution | |
| 8713030U | In distribution | |
| 8713030U-99 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kangaroo | Cardinal Health | 61 |
| Kangaroo | Cardinal Health 200, LLC | 54 |
| Infinity | Zevex, Inc. | 24 |
| Infinity Enteral Feeding Pump | Zevex, Inc. | 14 |
| Infinity Orange Enteral Feeding Pump | Zevex, Inc. | 8 |
| Medline | Medline Industries, Inc. | 3 |
| Sentinel® | Alcor Scientific LLC | 3 |
| Novum IQ | Baxter Healthcare Corporation | 2 |
| Infinity Small Volume Feeding Bag and Set | Zevex, Inc. | 2 |
| Moog Medical Infinity Pole Clamp | Zevex, Inc. | 2 |
| Vesco Medical 500mL Bag (PVC) Q Pump Feed Set with ENFit | Vesco Medical LLC | 1 |
| MedSystem III | BD Switzerland Sàrl | 1 |
Showing 12 of 26. All products under Pump, Infusion, Enteral
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | UDI-DI | 2024-06-14 | Class II | Device Design | Perfusor Space Syringe Pump’s instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, an | 4519 |
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.