Starling
The Starling Monitor provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function, as well as blood pressure parameters and blood…
The Starling Monitor provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function, as well as blood pressure parameters and blood oxygen saturation levels.
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 | Cheetah Medical (Israel) Ltd |
|---|---|
| FDA product code | DSB |
| Device type | Plethysmograph, Impedance |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2770 |
| Record published | 2022-08-12 |
| Record revised | 2023-08-25 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 15 to 85 % RH; Storage environment temperature 5 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CMMST5 | In distribution | |
| CMMST5S | In distribution |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2022-09-02 | Class III | Process control | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. | 9,671 units |
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.