Cardinal Health
Interventional Central Line PK
3manufacturers in China registered for this device type
20,409catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-10 |
| Record revised | 2022-06-17 (version 5) |
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 of 2, case of 3, case of 4, case of 6, case of 5, case |
| Distribution end date | 2017-10-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCV56RH118 | In distribution | |
| SAN31PPN11 | In distribution | |
| SANCGCCC27 | In distribution | |
| SAN23CAA20 | In distribution | |
| SANCGCBAUE | In distribution | |
| SAN42ESUK4 | In distribution | |
| SAN56PIIMA | In distribution | |
| SAN4AOAJH7 | In distribution | |
| SAN21ATA11 | In distribution | |
| SBA2DEPCF3 | In distribution | |
| SAN11ANNBS | In distribution | |
| SANOCHACAA | In distribution | |
| SAN35BSMO6 | In distribution | |
| SAN24CIJ17 | In distribution | |
| SAN12LE761 | In distribution | |
| SAN54RHHH1 | In distribution | |
| SAN23PCCMB | In distribution | |
| SAN18BSVB5 | In distribution | |
| SAN69ADF34 | In distribution | |
| SAN51ADK26 | In distribution | |
| SAN42CLT27 | In distribution | |
| SAN29EPPAC | In distribution | |
| SAN73RSSJ2 | In distribution | |
| SAN14APRGE | In distribution | |
| SAN33VROU6 | In distribution | |
| SAN31CCS14 | In distribution | |
| SAN13CLAJB | In distribution | |
| SAN11NRLH7 | In distribution | |
| SANOCCLWYB | In distribution | |
| SAN12ANK47 | In distribution | |
| SAN11ADO10 | In distribution | |
| SAN33CAM11 | In distribution | |
| SAN69BSKT3 | In distribution | |
| SAN14BJ091 | In distribution | |
| SAN44ANHCF | In distribution | |
| SAN42CLML1 | In distribution | |
| SAN5AIRKS8 | In distribution | |
| SAN32CC83U | In distribution | |
| SAN3LCLM39 | In distribution | |
| 36-1674A | In distribution | |
| SAN73LHVHF | In distribution | |
| SAN11CC211 | In distribution | |
| SAN33CAM26 | In distribution | |
| SAN11OADMK | In distribution | |
| SAN19CLCHM | In distribution | |
| SAN23CT231 | In distribution | |
| SAN2DCLC12 | In distribution | |
| SAN3ILHJ12 | In distribution | |
| SAN34IRHFH | In distribution | |
| SANMIANAV7 | In distribution | |
| SAN32IMF18 | In distribution | |
| SAN41AOBS3 | In distribution | |
| SANOCAPGT7 | In distribution | |
| SAN95HPD19 | In distribution | |
| SAN73CLC17 | In distribution | |
| SANCGCBA13 | In distribution | |
| SANHDAPUM6 | In distribution | |
| SBA56IPIMC | In distribution | |
| SAN21ANHV4 | In distribution | |
| SANDHEPMC1 | In distribution | |
| SAN11CLB12 | In distribution | |
| SAN31EPCD9 | In distribution | |
| SAN73CLNVL | In distribution | |
| SAN57PM802 | In distribution | |
| SAN69MIMRE | In distribution | |
| SAN7AINP12 | In distribution | |
| SAN11PR117 | In distribution | |
| SAN23AGB44 | In distribution | |
| SAN23APWB5 | In distribution | |
| SAN33CLOUC | In distribution | |
| SAN13BS603 | In distribution | |
| SAN56PVUVS | In distribution | |
| SANOCIRGSA | In distribution | |
| SAN34HCBH5 | In distribution | |
| SAN73ANR12 | In distribution | |
| SANHDSPRV3 | In distribution | |
| SAN24BIJ27 | In distribution | |
| SAN12APHF1 | In distribution | |
| SAN54PPEL3 | In distribution | |
| SAN7AEPPNA | In distribution | |
| SAN45ADIMB | In distribution | |
| SAN31ANCM1 | In distribution | |
| SAN54APDI9 | In distribution | |
| SAN21BPAR3 | In distribution | |
| SAN57CAVAO | In distribution | |
| SAN55BSMM5 | In distribution | |
| SAN5BAMHC5 | In distribution | |
| SAN3BIPKF6 | In distribution | |
| SAN41PR220 | In distribution | |
| SAN24BIJ25 | In distribution | |
| SAN11AMLV2 | In distribution | |
| SAN35PMJ17 | In distribution | |
| SAN41BS269 | In distribution | |
| SAN63EPMAD | In distribution | |
| SBA5AADKHC | In distribution | |
| SAN18AGV13 | In distribution | |
| SCV29TTCCA | In distribution | |
| SAN42CLN12 | In distribution | |
| SANHDJTVCF | In distribution | |
| PC57OTP16 | In distribution | |
| SAN63EPSTE | In distribution | |
| SAN7AAPEC1 | In distribution | |
| SAN11CC345 | In distribution | |
| SANOCANGMC | In distribution | |
| SAN30PRAG7 | In distribution | |
| SAN2494561 | In distribution | |
| SAN35PCCRH | In distribution | |
| SAN95HPD25 | In distribution | |
| SAN95HPD20 | In distribution | |
| SAN3JAPKSI | In distribution | |
| SAN35MIBL2 | In distribution | |
| SAN12SXGT3 | In distribution | |
| SAN73CCNV2 | In distribution | |
| SAN30AYPR2 | In distribution | |
| SAN56RPPC1 | In distribution | |
| SAN3BIRWK1 | In distribution | |
| SAN13ARC10 | In distribution | |
| SAN13CAEXJ | In distribution | |
| SAN16APSH8 | In distribution | |
| SAN32PCFCK | In distribution | |
| SANCGLCAUG | In distribution | |
| SAN21ATCHB | In distribution | |
| SAN35CCBPT | In distribution | |
| SCV7EEPJCA | In distribution | |
| SAN43HCJMD | In distribution | |
| SAN73IRKF6 | In distribution | |
| SAN26ADHRT | In distribution | |
| SAN53AOPA3 | In distribution | |
| SAN29FAMHM | In distribution | |
| SAN40PEE11 | In distribution | |
| SBA5AADKH2 | In distribution | |
| SAN43RANO4 | In distribution | |
| SAN21ATCHC | In distribution | |
| SANHFCLCPA | In distribution | |
| SLC63EPM11 | In distribution | |
| SAN13APBIJ | In distribution | |
| SAN23ANALI | In distribution | |
| SANCGPLAU6 | In distribution | |
| SAN12PPGOD | In distribution | |
| SAN21CCDC6 | In distribution | |
| SAN11ACDMP | In distribution | |
| SAN18FMTV2 | In distribution | |
| SAN73ATKAB | In distribution | |
| SAN56PVUV2 | In distribution | |
| SANCGBSHC5 | In distribution | |
| SAN11IDOEC | In distribution | |
| SAN7CANNHD | In distribution | |
| SAN31CCSGK | In distribution | |
| SAN57PD00M | In distribution | |
| SANHDATV16 | In distribution | |
| SAN21CC406 | In distribution | |
| SAN43AGM17 | In distribution | |
| SAN4AATJH5 | In distribution | |
| SAN57LC011 | In distribution | |
| SAN31ANCMW | In distribution | |
| SCV41APPD3 | In distribution | |
| SAN4ACCJH4 | In distribution | |
| SCVHDEPRV1 | In distribution | |
| SAN42CLML2 | In distribution | |
| SANCGAPPH5 | In distribution | |
| SAN55BAK17 | In distribution | |
| SANCGEPC29 | In distribution | |
| SAN24CVWM5 | In distribution | |
| SANCGBSMS9 | In distribution | |
| SAN3BIPK48 | In distribution | |
| SAN13CLETF | In distribution | |
| SANHDADSN1 | In distribution | |
| SAN55CPMM7 | In distribution | |
| SAN3ISPJ14 | In distribution | |
| SAN4ARBJH4 | In distribution | |
| SAN1DMTU10 | In distribution | |
| SANHBRPHS1 | In distribution | |
| SAN73ANSU4 | In distribution | |
| SAN1FANU37 | In distribution | |
| SAN3BADK43 | In distribution | |
| SAN69ADF11 | In distribution | |
| SANOCCPJCG | In distribution | |
| SANCGAPBM7 | In distribution | |
| SANCGCCC42 | In distribution | |
| SAN32EPFSX | In distribution | |
| SAN43PRUSJ | In distribution | |
| SAN4FCLWMJ | In distribution | |
| SAN54CPEL3 | In distribution | |
| SANCGCDAUL | In distribution | |
| SAN30BSPR2 | In distribution | |
| SAN31AGSLZ | In distribution | |
| SAN35MDBLW | In distribution | |
| SANCGAPFSF | In distribution | |
| SAN14JUMHU | In distribution | |
| SAN21PPHOI | In distribution | |
| SBA69ADS33 | In distribution | |
| SANCGIRAU3 | In distribution | |
| SAN59BAPN2 | In distribution | |
| SCV22VAJMH | In distribution | |
| SAN11BSLDK | In distribution | |
| SANOCFMGHD | In distribution | |
| SAN7AHCPN2 | In distribution | |
| SCVVXPMCCA | In distribution | |
| SAN11ACLV2 | In distribution | |
| SAN21CLA12 | In distribution | |
| SAN11BSL17 | In distribution | |
| SAN69CLLDB | In distribution | |
| SCVHDHCRVS | In distribution | |
| SAN34CIAV3 | In distribution | |
| SAN44PCMH2 | In distribution | |
| SAN69CCEC3 | In distribution | |
| SAN35APGVB | In distribution | |
| SAN12BSKG6 | In distribution | |
| SCV23EBFM2 | In distribution | |
| SAN69ANK38 | In distribution | |
| SAN29FARME | In distribution | |
| SAN43AGWJF | In distribution | |
| SAN51PDUS4 | In distribution | |
| SAN73APKM7 | In distribution | |
| SAN36CIASP | In distribution | |
| CHIP99AG13 | In distribution | |
| SAN13CLAJ8 | In distribution | |
| SAN48NDBC5 | In distribution | |
| SAN30BVP26 | In distribution | |
| SAN35APGVA | In distribution | |
| SAN24CTJMH | In distribution | |
| SAN51ADKK2 | In distribution | |
| SAN3BBPKV1 | In distribution | |
| SANMHNRMH2 | In distribution | |
| SANCGANA22 | In distribution | |
| SAN22CCC13 | In distribution | |
| SAN11APF27 | In distribution | |
| SAN81APB12 | In distribution | |
| SANOCOIHO8 | In distribution | |
| SBA69ADS24 | In distribution | |
| SAN41CPNT2 | In distribution | |
| SAN3ISPJ28 | In distribution | |
| SANOCATW16 | In distribution | |
| SAN6BCCOM5 | In distribution | |
| SAN11ADBL6 | In distribution | |
| SAN56CLDMG | In distribution | |
| SAN44ADMH4 | In distribution | |
| SAN2DCLCF7 | In distribution | |
| SAN23CACM3 | In distribution | |
| SANOCCACC2 | In distribution | |
| SANCGCARI4 | In distribution | |
| SAN21PCDCK | In distribution | |
| SAN35BSMOH | In distribution | |
| SAN3ISAJC6 | In distribution | |
| SAN23PMPR6 | In distribution | |
| SANMHAHNE2 | In distribution | |
| SAN21LPMCA | In distribution | |
| SAN69IRUSB | In distribution | |
| SAN11CCTR8 | In distribution | |
| SAN11FARTB | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merit Medical® | Merit Medical Systems, Inc. | 3,927 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2,085 |
| ACS | American Contract Systems, Inc. | 428 |
| DeRoyal | Deroyal Industries, Inc. | 283 |
| Aligned Medical Solutions | Aligned Medical Solutions | 120 |
| Regard™ | ROi CPS LLC | 57 |
| Stradis Healthcare | Stradis Healthcare | 33 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 23 |
| Namic | Medline Industries, Inc. | 21 |
| basixCOMPAK™ | Merit Medical Systems, Inc. | 8 |
| Stradis | Stradis Healthcare | 7 |
| AccessPLUS™ | Merit Medical Systems, Inc. | 6 |
Showing 12 of 49. All products under Angiography/Angioplasty Kit
Recalls Naming This Product
2 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 | 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 | 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 | Closed |
|---|---|---|---|---|---|
| 2021-02-11 | Class II | Process control | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pac | 298 units | 2022-12-22 |
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.