Cardinal Health
Kit,carotid Endarterectomy,bid
1manufacturer
40,731catalogue numbers in this listing
6recalls on this code
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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-24 |
| Record revised | 2022-06-17 (version 6) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case, case of 2, case of 3, case of 4, case of 5, case of 6 |
| Distribution end date | 2017-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCVDHCVVMA | In distribution | |
| 20-1303F | In distribution | |
| PC5777806 | In distribution | |
| SAN21CC626 | In distribution | |
| SCV41OHT36 | In distribution | |
| PC15OT977 | In distribution | |
| PV3LCVGNF | In distribution | |
| PVCGAFAU2 | In distribution | |
| SCV11DPLHK | In distribution | |
| PHVMLT225 | In distribution | |
| SCV33CDGND | In distribution | |
| SANHBDPCHD | In distribution | |
| PV43HEE17 | In distribution | |
| PV41OHUN6 | In distribution | |
| SCVHDOPS21 | In distribution | |
| SCVOCTULEH | In distribution | |
| SAN57PMV10 | In distribution | |
| SANHBOHECB | In distribution | |
| SCV35OPM24 | In distribution | |
| SCV43CV340 | In distribution | |
| SAN42APSF2 | In distribution | |
| SUTCGVBDN7 | In distribution | |
| PC08OHRH4 | In distribution | |
| PV11OP322 | In distribution | |
| SANW1PCM11 | In distribution | |
| PC24CGAMMB | In distribution | |
| PC3BVSUSI | In distribution | |
| SCV5FCAMM3 | In distribution | |
| SCVOCOHSF4 | In distribution | |
| PV40CG842 | In distribution | |
| PV45OVRCB | In distribution | |
| SCV13VSCO2 | In distribution | |
| SCVCGABAU1 | In distribution | |
| SCV49HSMBN | In distribution | |
| SAN29PCPC7 | In distribution | |
| SAN3BEPKFC | In distribution | |
| SCV3LTAAH1 | In distribution | |
| SANOCPPVH7 | In distribution | |
| PV63CDB42 | In distribution | |
| SAN23PMPRB | In distribution | |
| SCV3DCVMMF | In distribution | |
| SCV40BCABJ | In distribution | |
| PV41VAUN1 | In distribution | |
| SCVCGCOAUR | In distribution | |
| PVVXCAEA3 | In distribution | |
| SRI0VPMUMB | In distribution | |
| SAN11RVMMB | In distribution | |
| SCV40AVABB | In distribution | |
| SCVHFPCACF | In distribution | |
| PVV1AVGS3 | In distribution | |
| SCVHBCVEC1 | In distribution | |
| SCV55FPPM1 | In distribution | |
| SCV23HOF15 | In distribution | |
| 20-1303M | In distribution | |
| SCV12CGYH8 | In distribution | |
| PV40CG81C | In distribution | |
| SAN54PPHVA | In distribution | |
| PVOCOH145 | In distribution | |
| SAN53DAVSA | In distribution | |
| SCV18NV30D | In distribution | |
| SCV11VAN25 | In distribution | |
| PC7ATAHS5 | In distribution | |
| SBA22CEMCI | In distribution | |
| SCV23OH05X | In distribution | |
| SCV56OH913 | In distribution | |
| SANOCEPCO2 | In distribution | |
| SAN35PMJ12 | In distribution | |
| SAN33PMDW4 | In distribution | |
| PVHDMJ174 | In distribution | |
| SCVCGCHRIF | In distribution | |
| SCV45CVVH3 | In distribution | |
| SCV11LIJK1 | In distribution | |
| SAN33AEAH1 | In distribution | |
| SAN4JCCCMC | In distribution | |
| PC73OH623 | In distribution | |
| SCV30PDPR7 | In distribution | |
| SCV32OHJ10 | In distribution | |
| PCVMOHA415 | In distribution | |
| PV40OVRJB | In distribution | |
| PVOCCANST | In distribution | |
| SCVHDOHGW5 | In distribution | |
| PV36OHTR3 | In distribution | |
| PV30MAP17 | In distribution | |
| SCV36CVUNI | In distribution | |
| SCV73HPSV6 | In distribution | |
| SCVCGPPAC4 | In distribution | |
| SCVOCCBW12 | In distribution | |
| PVOCVDNH2 | In distribution | |
| SCV35DHBJF | In distribution | |
| PPV2OH344 | In distribution | |
| SCV73PPJC1 | In distribution | |
| SAN41PCHM3 | In distribution | |
| SCV57ORPAF | In distribution | |
| SCV7CPAGR1 | In distribution | |
| SCV12ETWCE | In distribution | |
| SAN35CVBL3 | In distribution | |
| SCV40VAAHB | In distribution | |
| SCV33OHADC | In distribution | |
| SAN23PMAM5 | In distribution | |
| SCV14VPC22 | In distribution | |
| SCV29CG64P | In distribution | |
| SAN11EVMME | In distribution | |
| SLC5AVPKF1 | In distribution | |
| PCCGVPCD1 | In distribution | |
| SAN42OHN15 | In distribution | |
| PVCGOHB28 | In distribution | |
| SCVCGAPA62 | In distribution | |
| SCV23PEDU3 | In distribution | |
| SAN13PCBI5 | In distribution | |
| SCV11ECCPO | In distribution | |
| PVSVEXRMT | In distribution | |
| SCVVMOHCR8 | In distribution | |
| SAN21MVAR1 | In distribution | |
| SCV30AFPR2 | In distribution | |
| PVW1CVN10 | In distribution | |
| SCV26CVFG9 | In distribution | |
| PCVXOTCC5 | In distribution | |
| PHVMTH224 | In distribution | |
| SCVHFSCF10 | In distribution | |
| SCV73AVKP3 | In distribution | |
| SCVX4LHPRA | In distribution | |
| SANDHEPCFA | In distribution | |
| SANDKIRFL4 | In distribution | |
| SCV15AVF20 | In distribution | |
| SCV11VCUHA | In distribution | |
| SCV11PVJK1 | In distribution | |
| PCVMAVBW3 | In distribution | |
| SAN13LPCA1 | In distribution | |
| SCV33OHBVP | In distribution | |
| SCVCGPAACC | In distribution | |
| SCV8FOHB11 | In distribution | |
| SAN43PTIB4 | In distribution | |
| SCV56CH228 | In distribution | |
| PVOCOH922 | In distribution | |
| SCV5CVPGSL | In distribution | |
| SCV4AAFJ17 | In distribution | |
| SAN4JCCCM4 | In distribution | |
| SCV22OHJHE | In distribution | |
| PVVNOH25B | In distribution | |
| SCV21CPCA3 | In distribution | |
| SCV43PCWJ8 | In distribution | |
| PVVZOYBMB1 | In distribution | |
| PVVZCVAMB2 | In distribution | |
| SCV12MVU11 | In distribution | |
| SCVHDCPRVL | In distribution | |
| PC41OTBUE | In distribution | |
| CHIP99MV21 | In distribution | |
| PC81AANMJ | In distribution | |
| PGVMAVBJ6 | In distribution | |
| PV08MVG12 | In distribution | |
| SCV12HVKGS | In distribution | |
| SCV30HPPRL | In distribution | |
| SAN11EPCPR | In distribution | |
| SCV11OH41B | In distribution | |
| SCV54PVTM6 | In distribution | |
| SCV1DCT617 | In distribution | |
| SCV51CH59T | In distribution | |
| SCV69HTFC1 | In distribution | |
| SAN4JCCHPB | In distribution | |
| PV08AAG13 | In distribution | |
| SCV12VPU12 | In distribution | |
| SCV4AMAJHL | In distribution | |
| SCVCGAPA34 | In distribution | |
| SAN11PDHM2 | In distribution | |
| SCV38COSEH | In distribution | |
| SCVHFAPUVA | In distribution | |
| SCV11VMM11 | In distribution | |
| SCV51VLK42 | In distribution | |
| SAN11LRLDA | In distribution | |
| PCVMCR222 | In distribution | |
| PG40THSL1 | In distribution | |
| SCV7CFDYN1 | In distribution | |
| SCV21THAR4 | In distribution | |
| SCV4ACVJHK | In distribution | |
| SANHDPPBV3 | In distribution | |
| SCVCGCOAUT | In distribution | |
| PVV2CPNYC | In distribution | |
| SCV51BPMR9 | In distribution | |
| SCV37CVJO5 | In distribution | |
| SCVCGCPA11 | In distribution | |
| PC23HSSM11 | In distribution | |
| 19-6608I | In distribution | |
| SCV18VAMC8 | In distribution | |
| PC5ACGKS2 | In distribution | |
| SCV4CVCCW4 | In distribution | |
| PC37OHM18 | In distribution | |
| SAN11PCMO1 | In distribution | |
| SCV13LRBI5 | In distribution | |
| SCV40CAAE3 | In distribution | |
| SCV13PAET5 | In distribution | |
| PVV1CBWC6 | In distribution | |
| SCV35DM376 | In distribution | |
| SANCGVPSG4 | In distribution | |
| SCV5CVPBN2 | In distribution | |
| SCV45OPR11 | In distribution | |
| SCV34BHMLD | In distribution | |
| SBAOCVPVHA | In distribution | |
| SCV13PCBC3 | In distribution | |
| SCVW1CVPOG | In distribution | |
| SCV51CH591 | In distribution | |
| PC3LOHSGP | In distribution | |
| SCV11OH241 | In distribution | |
| SCV21APSJD | In distribution | |
| PVVNVSCH3 | In distribution | |
| SCVCNCTLHE | In distribution | |
| PV60AANB3 | In distribution | |
| SAN73VPTA4 | In distribution | |
| SCVHFOHM10 | In distribution | |
| SCV11OH249 | In distribution | |
| SBAOCLDL13 | In distribution | |
| SCV41CAAMT | In distribution | |
| SCV31OHSKL | In distribution | |
| PV24EVJM2 | In distribution | |
| SCV8FVSBC9 | In distribution | |
| SCV56PMIM3 | In distribution | |
| SCV15AVF10 | In distribution | |
| SCVCGAPA68 | In distribution | |
| SCV54BHHV6 | In distribution | |
| SCVOCTPE12 | In distribution | |
| SAN34INPM4 | In distribution | |
| SAN11EPUH2 | In distribution | |
| PC46OHDLD | In distribution | |
| SCV73OHT13 | In distribution | |
| SAN35PPMB2 | In distribution | |
| SCV13PCBCD | In distribution | |
| SCVHFOHSW3 | In distribution | |
| 20C8840D | In distribution | |
| SCV35CEBL9 | In distribution | |
| SCV18NV303 | In distribution | |
| SCV11CTR13 | In distribution | |
| SLC33VPCLH | In distribution | |
| SAN41EPUNC | In distribution | |
| SANOCEPVH3 | In distribution | |
| PVVZCAMBL | In distribution | |
| SAN11BIJOF | In distribution | |
| SCV56HO20G | In distribution | |
| SCV13MCMGK | In distribution | |
| SCVVAOHGMC | In distribution | |
| PCCGOH55V | In distribution | |
| SCV13PCBCF | In distribution | |
| SCVW1VSHF3 | In distribution | |
| SCV5DVCUM2 | In distribution | |
| SCV33HAO11 | In distribution | |
| SCVV1TPFSA | In distribution | |
| SCV11ECCPL | In distribution | |
| SCV12VMFSZ | In distribution | |
| SCV11HVLD6 | In distribution | |
| SCV57HVVA2 | In distribution | |
| SAN1FPMUL3 | In distribution | |
| PV24OT566 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 51 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2026-07-29 | Class II | Process change control | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These | 2448 units |
| Cardinal Health 200, LLC | UDI-DI | 2024-11-08 | Class II | Nonconforming Material/Component | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | 512,786 total units |
| Cardinal Health 200, LLC | UDI-DI | 2024-11-08 | Class II | Material/Component Contamination | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 973,785 total units |
| Cardinal Health 200, LLC | UDI-DI | 2024-05-29 | Class II | Device Design | Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are i | 136753 units |
| Cardinal Health 200, LLC | UDI-DI | 2024-05-29 | Class II | Device Design | Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are i | 17445 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-08-16 | Class II | Material/Component Contamination | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | 13,351 total packs |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 80 kits |
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.