TandemLife LifeSPARC
LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
1manufacturer
3catalogue 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 | Cardiacassist, Inc., United States |
|---|---|
| FDA product code | KRI |
| Device type | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4200 |
| Record published | 2020-06-01 |
| Record revised | 2024-12-11 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2024-12-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5840-2417 | Withdrawn | |
| 5840-0000 | Withdrawn | |
| 5840-2415 | Withdrawn |
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
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.