CDI™ Blood Parameter Monitoring System 550
Monitor Pole Clamp, 4.5" Short, Calibrator Mount, for use with the CDI System 550 Monitor
1manufacturer
3catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | KRI |
| Device type | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-07-29 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Storage | Handling environment humidity 5 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CDI517 | In distribution | |
| CDI519 | In distribution | |
| CDI518 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bracket | LivaNova USA, Inc. | 16 |
| Accessory Equipment, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 15 |
| VivaCart | CardioQuip | 14 |
| Capiox | Terumo Corp. | 12 |
| CentriMag™ | Thoratec Corp. | 11 |
| LifeSPARC | Cardiacassist, Inc. | 9 |
| Quantum | Spectrum Medical Ltd | 8 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 8 |
| Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 6 |
| Novatemp | Novamed-USA | 5 |
| Inspire | Sorin Group Italia SRL | 5 |
| Holder | Eurosets SRL | 4 |
Showing 12 of 108. All products under Accessory Equipment, Cardiopulmonary Bypass
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-08-12 | Not classified | Incorrect or no expiration date | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. | 1,531,440 devices | 2012-06-20 |
| 2011-03-01 | Class II | Device Design | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line | 165 units | 2014-11-06 |
| 2009-10-02 | Class II | Labeling design | Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch and two inch conne | 33 units | 2013-01-29 |
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.