Capiox
Device Holder
1manufacturer
12catalogue numbers in this listing
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 Corp., Japan |
|---|---|
| FDA product code | KRI |
| Device type | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-06-30 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: This way up,Fragile. Keep dry. Keep away from sunlight. |
| Packaging | Pack of 4, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XX*CXH05 | In distribution | |
| XX*XH071 | In distribution | |
| XX*CXH05AD | In distribution | |
| XX*CXH18R | In distribution | |
| XX*CXH25F | In distribution | |
| XX*CXH18 | In distribution | |
| XX*XH081 | In distribution | |
| XX*CXH15 | In distribution | |
| XX*XH041 | In distribution | |
| XX*XH051 | In distribution | |
| XX*CXH05R | In distribution | |
| XX*XH032 | 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 |
| 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 |
| Forceps | LivaNova USA, Inc. | 4 |
Showing 12 of 108. All products under Accessory Equipment, Cardiopulmonary Bypass
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.