ICU Medical
Safeset™ IV Tubing with Reservoir and Blood Sampling Port and 03 ml Squeeze Flush Device
5manufacturers in China registered for this device type
21catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K932188 |
| Record published | 2021-08-29 |
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 20, case of 25, case of 30, box of 10, box of 20, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42338-01 | In distribution | |
| 011-0H411-01 | In distribution | |
| 46101-98 | In distribution | |
| 46056-67 | In distribution | |
| 46200-41 | In distribution | |
| 46056-64 | In distribution | |
| 42552-02 | In distribution | |
| 42322-66 | In distribution | |
| 46105-96 | In distribution | |
| 42327-02 | In distribution | |
| 42658-01 | In distribution | |
| 42002-13 | In distribution | |
| 42328-66 | In distribution | |
| 46105-05 | In distribution | |
| 42303-02 | In distribution | |
| 46102-50 | In distribution | |
| 46050-67 | In distribution | |
| 46200-64 | In distribution | |
| 46102-26 | In distribution | |
| 42653-66 | In distribution | |
| 46200-30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
| Deltran | Utah Medical Products, Inc. | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070979 | 2007-09-19 |
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.