Coeur
7 in. Transfer set with Long Spike
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Coeur, Inc., United States |
|---|---|
| FDA product code | FPK |
| Device type | Tubing, Fluid Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K063114 |
| Record published | 2016-07-14 |
| Record revised | 2019-02-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicida |
| Packaging | Shipper of 2, case of 50 |
| Sizes | Length 7 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C405-3041 | Length 7 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| High Pressure Tubing | Merit Medical Systems, Inc. | 68 |
| Vygon | Vygon Corp. | 67 |
| Medex | ICU Medical, Inc | 41 |
| High Pressure Tubing, Keep™ | Merit Medical Systems, Inc. | 25 |
| Pressure Monitor Tubing | Merit Medical Systems, Inc. | 21 |
| Medrad® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) | Bayer Medical Care Inc. | 16 |
| Merit Medical® | Merit Medical Systems, Inc. | 10 |
| Kew Medical | Douglas Medical Products, Inc | 8 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 5 |
| CIV | Emed Technologies Corporation | 5 |
| Medrad® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube | Bayer Medical Care Inc. | 5 |
| Lifeshield | ICU Medical, Inc | 5 |
Showing 12 of 51. All products under Tubing, Fluid Delivery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063114 | 2007-02-09 |
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.