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APERTO OTW Paclitaxel Releasing Hemodialysis Shunt Balloon Dilatation Catheter紫杉醇释放高压分流球囊扩张导管
| Brand | CARDIONOVUM（凯德诺） |
|---|---|
| Manufacturer | CARDIONOVUM GmbH德国凯德诺有限责任公司 |
| Production Address | Am Bonner Bogen2，53227 Bonn，Germany |
| Intended Use | The product is suitable for the expansion treatment of stenotic lesions in the autologous arteriovenous fistula dialysis pathway of hemodialysis patients.该产品适用于血液透析患者的自体动静脉瘘透析通路狭窄病变扩张治疗。 |
| References | AP 6.00-40 OTW, APL 6.00-40 OTW, APS 6.00-40 OTW……… |
| Manufacturer’s Website | https://cardionovum.de/aperto/ |
| Product Brochure | |
| Registration Certificate | 国械注进20203030167 |
Brand
The product is composed of a drug-coated balloon, internal distal tube, marking tape, hydrophilic coating, double lumen tube, stress buffer, bonding tube, proximal guidewire tube, and double lumen tube seat. The drug contained in the coating on the surface of the drug-coated balloon is paclitaxel, the dose is 3.0μg/mm2, and the drug carrier matrix is purple ammonium salt. Sterilized by ethylene oxide, for one-time use. The shelf life is two years.
产品由药物涂层球囊、内部远端管、标记带、亲水涂层、双腔管、应力缓冲件、粘结管、近端导丝管、双腔管座组成。药物涂层球囊表面涂层中所含药物为紫杉醇，剂量为3.0μg/mm2，载药基质为紫胶铵盐。环氧乙烷灭菌，一次性使用。 货架有效期为两年。
Products List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| AP 10.00-20 OTW | 05906190157508 | 03-13-06 | AP 10.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 10.00-40 OTW | 05906190157522 | 03-13-06 | AP 10.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 10.00-60 OTW | 05906190157546 | 03-13-06 | AP 10.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 10.00-80 OTW | 05906190157560 | 03-13-06 | AP 10.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 4.00-20 OTW | 05906190157027 | 03-13-06 | AP 4.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 4.00-40 OTW | 05906190157041 | 03-13-06 | AP 4.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 4.00-60 OTW | 05906190157065 | 03-13-06 | AP 4.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 4.00-80 OTW | 05906190157089 | 03-13-06 | AP 4.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 5.00-20 OTW | 05906190157102 | 03-13-06 | AP 5.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 5.00-40 OTW | 05906190157126 | 03-13-06 | AP 5.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 5.00-60 OTW | 05906190157140 | 03-13-06 | AP 5.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 5.00-80 OTW | 05906190157164 | 03-13-06 | AP 5.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 6.00-20 OTW | 05906190157188 | 03-13-06 | AP 6.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 6.00-40 OTW | 05906190157201 | 03-13-06 | AP 6.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 6.00-60 OTW | 05906190157225 | 03-13-06 | AP 6.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 6.00-80 OTW | 05906190157249 | 03-13-06 | AP 6.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 7.00-20 OTW | 05906190157263 | 03-13-06 | AP 7.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 7.00-40 OTW | 05906190157287 | 03-13-06 | AP 7.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 7.00-60 OTW | 05906190157300 | 03-13-06 | AP 7.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 7.00-80 OTW | 05906190157324 | 03-13-06 | AP 7.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 8.00-20 OTW | 05906190157348 | 03-13-06 | AP 8.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 8.00-40 OTW | 05906190157362 | 03-13-06 | AP 8.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 8.00-60 OTW | 05906190157386 | 03-13-06 | AP 8.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 8.00-80 OTW | 05906190157409 | 03-13-06 | AP 8.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 9.00-20 OTW | 05906190157423 | 03-13-06 | AP 9.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 9.00-40 OTW | 05906190157447 | 03-13-06 | AP 9.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 9.00-60 OTW | 05906190157461 | 03-13-06 | AP 9.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| AP 9.00-80 OTW | 05906190157485 | 03-13-06 | AP 9.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 10.00-20 OTW | 05906190157782 | 03-13-06 | APL 10.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 10.00-40 OTW | 05906190157799 | 03-13-06 | APL 10.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 10.00-60 OTW | 05906190157805 | 03-13-06 | APL 10.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 10.00-80 OTW | 05906190157843 | 03-13-06 | APL 10.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 4.00-20 OTW | 05906190157607 | 03-13-06 | APL 4.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 4.00-40 OTW | 05906190157614 | 03-13-06 | APL 4.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 4.00-60 OTW | 05906190157621 | 03-13-06 | APL 4.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 4.00-80 OTW | 05906190157577 | 03-13-06 | APL 4.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 5.00-20 OTW | 05906190157638 | 03-13-06 | APL 5.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 5.00-40 OTW | 05906190157645 | 03-13-06 | APL 5.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 5.00-60 OTW | 05906190157652 | 03-13-06 | APL 5.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 5.00-80 OTW | 05906190157584 | 03-13-06 | APL 5.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 6.00-20 OTW | 05906190157669 | 03-13-06 | APL 6.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 6.00-40 OTW | 05906190157676 | 03-13-06 | APL 6.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 6.00-60 OTW | 05906190157683 | 03-13-06 | APL 6.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 6.00-80 OTW | 05906190157591 | 03-13-06 | APL 6.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 7.00-20 OTW | 05906190157690 | 03-13-06 | APL 7.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 7.00-40 OTW | 05906190157706 | 03-13-06 | APL 7.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 7.00-60 OTW | 05906190157713 | 03-13-06 | APL 7.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 7.00-80 OTW | 05906190157812 | 03-13-06 | APL 7.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 8.00-20 OTW | 05906190157720 | 03-13-06 | APL 8.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 8.00-40 OTW | 05906190157737 | 03-13-06 | APL 8.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 8.00-60 OTW | 05906190157744 | 03-13-06 | APL 8.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 8.00-80 OTW | 05906190157829 | 03-13-06 | APL 8.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 9.00-20 OTW | 05906190157751 | 03-13-06 | APL 9.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 9.00-40 OTW | 05906190157768 | 03-13-06 | APL 9.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 9.00-60 OTW | 05906190157775 | 03-13-06 | APL 9.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APL 9.00-80 OTW | 05906190157836 | 03-13-06 | APL 9.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 10.00-20 OTW | 05906190157492 | 03-13-06 | APS 10.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 10.00-40 OTW | 05906190157515 | 03-13-06 | APS 10.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 10.00-60 OTW | 05906190157539 | 03-13-06 | APS 10.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 10.00-80 OTW | 05906190157553 | 03-13-06 | APS 10.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 4.00-20 OTW | 05906190157010 | 03-13-06 | APS 4.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 4.00-40 OTW | 05906190157034 | 03-13-06 | APS 4.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 4.00-60 OTW | 05906190157058 | 03-13-06 | APS 4.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 4.00-80 OTW | 05906190157072 | 03-13-06 | APS 4.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 5.00-20 OTW | 05906190157096 | 03-13-06 | APS 5.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 5.00-40 OTW | 05906190157119 | 03-13-06 | APS 5.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 5.00-60 OTW | 05906190157133 | 03-13-06 | APS 5.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 5.00-80 OTW | 05906190157157 | 03-13-06 | APS 5.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 6.00-20 OTW | 05906190157171 | 03-13-06 | APS 6.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 6.00-40 OTW | 05906190157195 | 03-13-06 | APS 6.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 6.00-60 OTW | 05906190157218 | 03-13-06 | APS 6.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 6.00-80 OTW | 05906190157232 | 03-13-06 | APS 6.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 7.00-20 OTW | 05906190157256 | 03-13-06 | APS 7.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 7.00-40 OTW | 05906190157270 | 03-13-06 | APS 7.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 7.00-60 OTW | 05906190157294 | 03-13-06 | APS 7.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 7.00-80 OTW | 05906190157317 | 03-13-06 | APS 7.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 8.00-20 OTW | 05906190157331 | 03-13-06 | APS 8.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 8.00-40 OTW | 05906190157355 | 03-13-06 | APS 8.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 8.00-60 OTW | 05906190157379 | 03-13-06 | APS 8.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 8.00-80 OTW | 05906190157393 | 03-13-06 | APS 8.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 9.00-20 OTW | 05906190157416 | 03-13-06 | APS 9.00-20 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 9.00-40 OTW | 05906190157430 | 03-13-06 | APS 9.00-40 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 9.00-60 OTW | 05906190157454 | 03-13-06 | APS 9.00-60 OTW紫杉醇释放高压分流球囊扩张导管 |
| APS 9.00-80 OTW | 05906190157478 | 03-13-06 | APS 9.00-80 OTW紫杉醇释放高压分流球囊扩张导管 |
| Risk-Based Classification风险管理类别 |
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