Power Infuser
Pump Cartridge, Crystalloid/Colloid, 10 PER Case (IPN 0040-0050)
5manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2026-01-28 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature 0 to 0 °C; Handling environment temperature 0 to 0 °C; Storage environment atmospheric pressure from 0 KiloPascal; Storage environment humidity 0 to 0 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1110-0051 | In distribution | |
| 1110-0013-01 | In distribution | |
| 1110-0050 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172653 | 2018-07-18 |
| K090736 | 2009-05-20 |
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.