Flow Control Tubing
39 catalogue numbers from FCT 30mL/4h, listed by GO Medical Industries PTY. Ltd., Australia, under Pump, Infusion. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
39catalogue numbers in this listing
1510(k) clearance
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 | GO Medical Industries PTY. Ltd., Australia |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K910007 |
| Record published | 2017-05-16 |
| Record revised | 2024-04-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipping carton of 300, carton of 25, outer carton of 600, inner carton of 50, shipping carton of 180, carton of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FCT 30mL/4h | In distribution | |
| FCT 50ml/60mins (with syringe) | In distribution | |
| FCT 30mL/72h | In distribution | |
| FCT 30mL/2h | In distribution | |
| FCT 50mL/15min (with syringe) | In distribution | |
| FCT 50mL/24h | In distribution | |
| FCT 10mL/12h | In distribution | |
| FCT 10mL/4h | In distribution | |
| FCT 10mL/15min | In distribution | |
| FCT 30mL/60min | In distribution | |
| FCT 30mL/6h | In distribution | |
| FCT 10mL/5min | In distribution | |
| FCT 30mL/30min | In distribution | |
| FCT 60ml/90mins (with syringe) | In distribution | |
| FCT 50mL/15min | In distribution | |
| FCT 30mL/8h | In distribution | |
| FCT 50ml/90mins (with syringe) | In distribution | |
| FCT 30mL/15min | In distribution | |
| FCT 10mL/24h | In distribution | |
| FCT 50mL/30mins | In distribution | |
| FCT 10mL/2h | In distribution | |
| FCT 50mL/30mins (with syringe) | In distribution | |
| FCT 50mL/2hours | In distribution | |
| FCT 30mL/96h | In distribution | |
| FCT 50mL/60mins | In distribution | |
| FCT 30mL/24h | In distribution | |
| FCT 10mL/6h | In distribution | |
| FCT 50ml/24hours (with syringe) | In distribution | |
| FCT 60ml/90mins | In distribution | |
| FCT 50ml/2hours (with syringe) | In distribution | |
| FCT 50mL/90mins | In distribution | |
| FCT 10mL/60min | In distribution | |
| FCT 10mL/72h | In distribution | |
| FCT 30mL/5min | In distribution | |
| FCT 30mL/48h | In distribution | |
| FCT 30mL/12h | In distribution | |
| FCT 10mL/30min | In distribution | |
| FCT 10mL/48h | In distribution | |
| FCT 10mL/8h | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| 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 |
| Plum | ICU Medical, Inc | 14 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K910007 | 1993-11-02 |
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.