ReDS System
Fluid status monitor This catalog item may also be used by a health care provider, in the hospital or hospital like facilities, to obtain spot readings of multiple patients.
5manufacturers in China registered for this device type
7catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Sensible Medical Innovations Ltd., Israel |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Establishment | Manufacturer |
| 510(k) | K150095 |
| Record published | 2018-03-05 |
| Record revised | 2024-10-11 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 0 to 93 % RH; Storage environment temperature 32 to 122 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 15 to 93 % RH; Handling environment temperature 41 to 95 °F |
| Distribution end date | 2022-06-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V2.6 | Withdrawn | |
| V2.6 | Withdrawn | |
| V2.6 | Withdrawn | |
| V2.6 | Withdrawn | |
| V2.6 | Withdrawn | |
| V2.6 | Withdrawn | |
| V2.6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Finapres | Finapres Medical Systems B.V. | 14 |
| Hokanson | D. E. Hokanson, Inc. | 11 |
| EV1000 | Edwards Lifesciences Technology Sarl | 9 |
| Valhalla Scientific, Inc | Valhalla Scientific, Inc. | 9 |
| ReDS Pro System | Sensible Medical Innovations Ltd. | 6 |
| Avivo™ | Medtronic, Inc. | 3 |
| ICG cable | Cnsystems Medizintechnik GmbH | 3 |
| ECG cable | Cnsystems Medizintechnik GmbH | 3 |
| PhysioFlow | Manatec | 3 |
| uCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 3 |
| ReDS Wearable System | Sensible Medical Innovations Ltd. | 3 |
| Flying-V – finger cuff (medium) | Cnsystems Medizintechnik GmbH | 3 |
Showing 12 of 66. All products under Plethysmograph, Impedance
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180479 | 2019-02-28 |
| K150095 | 2015-08-06 |
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.