EmpowerCTA®+ Injector System
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN :…
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN : 37630039300747
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 | Bracco Injeneering, Switzerland |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Record published | 2016-09-20 |
| Record revised | 2024-04-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Dry environment; Handling environment temperature -29 to 60 °C; Handling environment humidity 0 to 85 % RH; Handling environment atmospheric pressure 10 to 110 KiloPascal |
| Distribution end date | 2019-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 017285 | In distribution | |
| 017285 | Withdrawn |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 System | Sensible Medical Innovations Ltd. | 7 |
| 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 |
Showing 12 of 66. All products under Plethysmograph, Impedance
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.