ICU Medical
Cath Lab Kit w/Waste Bag System, 3 Port "ON" Manifold (600 psi), dyePod™, Transpac™ IV, 12 cc Control Syringe, Syringes and Guidewire
11manufacturers in China registered for this device type
119catalogue numbers in this listing
2510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K932141 |
| Record published | 2021-08-29 |
| Record revised | 2019-01-23 (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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 25, case of 10, case of 20, case of 5, case of 50, case of 15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42370-01 | In distribution | |
| 42044-01 | In distribution | |
| 46093-36 | In distribution | |
| 42366-01 | In distribution | |
| 42343-02 | In distribution | |
| AG7801 | In distribution | |
| 46047-19 | In distribution | |
| AG7420 | In distribution | |
| 46096-26 | In distribution | |
| AG7986 | In distribution | |
| 46066-33 | In distribution | |
| 42386-01 | In distribution | |
| 46111-12 | In distribution | |
| 46073-17 | In distribution | |
| 46105-87 | In distribution | |
| 42341-02 | In distribution | |
| 46084-61 | In distribution | |
| 42041-01 | In distribution | |
| 46100-79 | In distribution | |
| 42376-01 | In distribution | |
| 46200-25 | In distribution | |
| 46099-57 | In distribution | |
| AG8020 | In distribution | |
| 46997-01 | In distribution | |
| 46093-25 | In distribution | |
| 46102-62 | In distribution | |
| 46084-10 | In distribution | |
| AG8095 | In distribution | |
| 42348-48 | In distribution | |
| 46050-24 | In distribution | |
| 46075-61 | In distribution | |
| 46095-56 | In distribution | |
| 46100-85 | In distribution | |
| 46096-45 | In distribution | |
| 42400-02 | In distribution | |
| 46078-52 | In distribution | |
| 42364-01 | In distribution | |
| 42317-01 | In distribution | |
| 42362-11 | In distribution | |
| AG8088 | In distribution | |
| 46073-70 | In distribution | |
| 46098-22 | In distribution | |
| 46098-96 | In distribution | |
| 46083-02 | In distribution | |
| B1473 | In distribution | |
| 42375-01 | In distribution | |
| 46056-36 | In distribution | |
| AG7891 | In distribution | |
| AG8019 | In distribution | |
| 42478-02 | In distribution | |
| 42052-01 | In distribution | |
| 42387-01 | In distribution | |
| 46098-94 | In distribution | |
| 46100-92 | In distribution | |
| 46071-40 | In distribution | |
| AG8053 | In distribution | |
| AG7398 | In distribution | |
| 46055-07 | In distribution | |
| 46100-99 | In distribution | |
| 46098-66 | In distribution | |
| 46078-17 | In distribution | |
| 42385-01 | In distribution | |
| 46098-35 | In distribution | |
| 46089-03 | In distribution | |
| 46050-58 | In distribution | |
| 46100-91 | In distribution | |
| 46096-25 | In distribution | |
| 46056-35 | In distribution | |
| 42436-01 | In distribution | |
| 46063-37 | In distribution | |
| 46071-63 | In distribution | |
| AG8074 | In distribution | |
| AG8021 | In distribution | |
| 46300-11 | In distribution | |
| 42432-48 | In distribution | |
| 46080-02 | In distribution | |
| 42900-03 | In distribution | |
| 46089-74 | In distribution | |
| 46100-29 | In distribution | |
| 46096-86 | In distribution | |
| 46066-13 | In distribution | |
| 42409-11 | In distribution | |
| 42342-02 | In distribution | |
| 46073-18 | In distribution | |
| 42610-45 | In distribution | |
| 42402-02 | In distribution | |
| 42398-01 | In distribution | |
| 46066-34 | In distribution | |
| 46098-16 | In distribution | |
| 46098-76 | In distribution | |
| 42901-02 | In distribution | |
| 46100-87 | In distribution | |
| 42372-01 | In distribution | |
| 46095-16 | In distribution | |
| 46057-18 | In distribution | |
| AG8075 | In distribution | |
| 46105-84 | In distribution | |
| 46069-61 | In distribution | |
| 46095-66 | In distribution | |
| AG7394 | In distribution | |
| 46300-50 | In distribution | |
| 46111-39 | In distribution | |
| 42377-01 | In distribution | |
| 42384-11 | In distribution | |
| 46095-22 | In distribution | |
| 46098-86 | In distribution | |
| 46100-83 | In distribution | |
| AG7878 | In distribution | |
| 42435-01 | In distribution | |
| 42374-01 | In distribution | |
| AG8137 | In distribution | |
| 42368-01 | In distribution | |
| 46098-56 | In distribution | |
| AG8131 | In distribution | |
| 42388-01 | In distribution | |
| 46083-11 | In distribution | |
| 46098-75 | In distribution | |
| 46078-16 | In distribution | |
| 42373-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063784 | 2007-04-16 |
| K052865 | 2005-12-22 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2012-04-17 | Class II | Nonconforming Material/Component | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. | 4625 | 2012-08-23 |
| ICU Medical, Inc | 510(k) number | 2012-04-17 | Class II | Nonconforming Material/Component | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. | 2012-08-23 | |
| ICU Medical, Inc | 510(k) number | 2012-04-17 | Class II | Nonconforming Material/Component | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded. | 2012-08-23 | |
| ICU Medical, Inc | 510(k) number | 2004-11-02 | Not classified | Other | Syringes could possibly allow air to enter the patient’s vascular system. | 62080 kits | 2005-07-25 |
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 |
|---|---|---|---|---|---|
| 2012-09-28 | Class II | Mixed-up of materials/components | ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set. | 60 | 2013-02-19 |
| 2004-11-02 | Not classified | Other | Syringes could possibly allow air to enter the patient’s vascular system. | 250 syringes | 2005-07-25 |
| 2004-11-02 | Not classified | Other | Syringes could possibly allow air to enter the patient’s vascular system. | 0 syringes | 2005-07-25 |
| 2004-11-02 | Not classified | Other | Syringes could possibly allow air to enter the patient’s vascular system. | 2050 syringes | 2005-07-25 |
| 2004-11-02 | Not classified | Other | Syringes could possibly allow air to enter the patient’s vascular system. | 8175 syringes | 2005-07-25 |
| 2004-10-20 | Not classified | Other | Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body. | 71,132 units. | 2012-04-11 |
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.