Cardinal Health
Pediatric Cardiac Cath Duplica
1manufacturer
2,706catalogue numbers in this listing
1recall
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 | OES |
| Device type | Cardiac Catheterization Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-07-05 |
| Record revised | 2018-07-17 (version 3) |
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 | 2017-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAN34CCINL | In distribution | |
| SAN11CCSBH | In distribution | |
| SAN23CDARD | In distribution | |
| SAN53CHVM7 | In distribution | |
| SAN69CCR11 | In distribution | |
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| SAN54CPAAE | In distribution | |
| SAN35CPMB1 | In distribution | |
| SAN12CTA17 | In distribution | |
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| SANDHCTPMI | In distribution | |
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| SAN69CK114 | In distribution | |
| SAN11CCSBJ | In distribution | |
| SAN11CBCHS | In distribution | |
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| SAN23CRVAC | In distribution | |
| SAN16CCS20 | In distribution | |
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| SAN69CCR21 | In distribution | |
| SANHDLHS13 | In distribution | |
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| SAN13CC556 | In distribution | |
| SAN12CC384 | In distribution | |
| SAN13CCCMC | In distribution | |
| SCVOCCTSRD | In distribution | |
| SAN7LCCWMB | In distribution | |
| SAN35CCSMD | In distribution | |
| SAN3BCCK15 | In distribution | |
| SAN69CSG19 | In distribution | |
| SAN35CPA10 | In distribution | |
| SAN12CC38C | In distribution | |
| SAN33CACHE | In distribution | |
| SAN41CCN12 | In distribution | |
| SANOCCCM10 | In distribution | |
| SAN38CCV11 | In distribution | |
| SAN3LCCSGG | In distribution | |
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| SAN19CCK43 | In distribution | |
| SAN35CPA39 | In distribution | |
| SRI0VCCU14 | In distribution | |
| SAN11CCN14 | In distribution | |
| SAN23CDA24 | In distribution | |
| SAN21CACA4 | In distribution | |
| SAN7CPCYN6 | In distribution | |
| SANRMCCOHC | In distribution | |
| SAN40CCA10 | In distribution | |
| SAN11LHH21 | In distribution | |
| SAN44CCHR9 | In distribution | |
| SAN69CCKR5 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 7,486 |
| Avid TruCustom | Avid Medical, Inc. | 1,173 |
| Centurion | Centurion Medical Products Corporation | 1,077 |
| Halyard | Avid Medical, Inc. | 1,032 |
| Medline Industries, Inc. | Centurion Medical Products Corporation | 775 |
| Medline | Medline Industries, Inc. | 465 |
| ACS | American Contract Systems, Inc. | 344 |
| Regard™ | ROi CPS LLC | 138 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 79 |
| Aligned Medical Solutions | Aligned Medical Solutions | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 24 |
| Namic | Medline Industries, Inc. | 14 |
Showing 12 of 18. All products under Cardiac Catheterization 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 | 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 | 2524 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.