Centurion Medical Products Corp
Lvad BI Weekly Maintenance KIT
1manufacturer
51catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2022-06-11 |
| Record revised | 2022-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5, case of 20, case of 6, case of 12, case of 15, case of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MNS13455 | In distribution | |
| MNS12265C | In distribution | |
| MNS15010 | In distribution | |
| DT22790B | In distribution | |
| MNS15425 | In distribution | |
| MNS15613 | In distribution | |
| MNS13350 | In distribution | |
| MNS13980 | In distribution | |
| DM1165B | In distribution | |
| CVI4775 | In distribution | |
| MNS15310 | In distribution | |
| CVI4500B | In distribution | |
| MNS15385 | In distribution | |
| MNS15620 | In distribution | |
| MNS13970 | In distribution | |
| MNS13455A | In distribution | |
| MNS13460 | In distribution | |
| MNS13805A | In distribution | |
| MNS13735 | In distribution | |
| DM715A | In distribution | |
| DT21355A | In distribution | |
| DM1325 | In distribution | |
| MNS15618 | In distribution | |
| MNS13710 | In distribution | |
| MNS15500 | In distribution | |
| MNS15425A | In distribution | |
| MNS13710A | In distribution | |
| MNS15631 | In distribution | |
| DT22790 | In distribution | |
| MNS15350 | In distribution | |
| MNS13455B | In distribution | |
| DM1245 | In distribution | |
| MNS13540 | In distribution | |
| MNS15345 | In distribution | |
| MNS15616 | In distribution | |
| DM1335 | In distribution | |
| DM1215A | In distribution | |
| CVI1010A | In distribution | |
| DT22790C | In distribution | |
| DT23000 | In distribution | |
| DM1250 | In distribution | |
| DM1165 | In distribution | |
| MNS13380 | In distribution | |
| MNS15230 | In distribution | |
| MNS13485 | In distribution | |
| DM1165A | In distribution | |
| MNS3010 | In distribution | |
| DM1240 | In distribution | |
| DT22790A | In distribution | |
| MNS15055 | In distribution | |
| CHT650 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Medline Industries, Inc. | Medline Industries, Inc. | 17,468 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| Halyard | Avid Medical, Inc. | 2,108 |
| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-24 | Class II | Packaging change control | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. | 21854 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 260 cases (1,200 units) |
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.