Klein Touch Pump
Klein Touch Pump is an infiltration pump that moves fluid from an IV bag into a patient under manual control of a healthcare professional. It is intended for trained professionals with…
Klein Touch Pump is an infiltration pump that moves fluid from an IV bag into a patient under manual control of a healthcare professional. It is intended for trained professionals with knowledge of total dosage and physician-issued dose orders. It is not intended for intravenous infusion.
Three rotating rollers create peristaltic pumping action in the compatible sterile Klein Touch tubing set. The pump can operate from electrical power or a battery. Its controls include a colour graphic LCD and dual air-activated foot switches.
Tubing Preparation
The pump is designed specifically for sterile, single-use KT20 tubing, which must be primed before use. The fluid pathway uses silicone tubing, and the pump includes a fixed-clamp three-roller mechanism.
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 | HK Surgical, Inc., United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K123822 |
| Record published | 2016-09-21 |
| Record revised | 2022-07-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2020-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KTP | In distribution | |
| KTP | Withdrawn |
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 |
|---|---|
| K123822 | 2013-09-27 |
| K031432 | 2003-08-07 |
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.