Minimax®
Oxygenator CB3381 Bioact Minimax S 4PKL
1manufacturer
1catalogue number
16510(k) clearances naming this product code
4recalls 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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K933586 |
| Record published | 2015-06-09 |
| Record revised | 2020-01-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Pack of 4 |
| Distribution end date | 2018-10-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB3381 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241352 | 2024-06-12 |
| K230640 | 2023-04-06 |
| K203111 | 2021-09-16 |
| K191444 | 2019-09-27 |
| K191029 | 2019-05-17 |
| K183490 | 2019-04-12 |
| K183511 | 2019-03-18 |
| K172984 | 2017-11-20 |
| K172626 | 2017-10-25 |
| K162896 | 2016-12-06 |
| K162016 | 2016-09-21 |
| K143073 | 2015-03-25 |
| K142784 | 2014-10-24 |
| K123314 | 2013-01-22 |
| K122827 | 2012-12-14 |
| K100645 | 2012-09-14 |
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 |
|---|---|---|---|---|---|
| 2016-11-16 | Class II | Process control | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiot | 5609 (663 US; 4946 OUS) | 2017-08-01 |
| 2013-07-17 | Class II | Process control | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. | 217 | 2014-02-04 |
| 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 106 | 2014-05-22 |
| 2008-10-17 | Not classified | Error in labeling | Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect “Recommended maximum blood flow | 408 | 2011-04-19 |
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.