Swabbable Valve Transfer Set
Swabbable-Valve Transfer Set for MR or CT bulk contrast and/or saline syringe filling (CT - SWABBABLE VALVE TRANSFER SET, SVTS) (60729202)
2manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Bayer Medical Care Inc., United States |
|---|---|
| FDA product code | FPK |
| Device type | Tubing, Fluid Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K031808 |
| Record published | 2016-09-24 |
| Record revised | 2021-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 40 °C; Handling environment temperature -20 to 60 °C; Handling environment humidity 0 to 95 % RH; Storage environment humidity 10 to 90 % RH |
| Packaging | Pack of 50, box of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SVTS | In distribution | |
| SVTS | In distribution | |
| SVTS | 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
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.