Sarns™ Modular Perfusion System 8000
CDI 500 Comm module for TCVS Sarns 8000
7manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1). 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 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | Guangdong | Specification developer | 7 |
Record
| Listed by | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | DSJ |
| Device type | Alarm, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1100 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K960916 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16417 | In distribution | |
| 7278 | In distribution | |
| 16418 | In distribution | |
| 147361 | In distribution | |
| 16414 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alarm, Blood-Pressure | GE Healthcare Finland OY | 1 |
| EEG Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Comen | Shenzhen Comen Medical Instruments Co., Ltd. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2011-08-29 | Not classified | Component change control | The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume. | 85 | 2013-03-08 |
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.