Recirculation Adapter/Priming Connector
This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous…
This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Bain Medical Equipment(Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
| Vital Healthcare (Guangzhou) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Gambro Renal Products S.A. DE C.V., Mexico |
|---|---|
| FDA product code | FJK |
| Device type | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| Establishment | Manufacturer |
| Record published | 2015-10-23 |
| Record revised | 2024-11-25 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: The accessory system must be stored in a dry place; Storage environment temperature 0 to 120 °F; Storage environment temperature -18 to 49 °C |
| Packaging | Case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 106283 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 58 |
| Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET | Nipro Medical Corporation | 12 |
| Hemodialysis Bloodlines | B. Braun Medical Inc. | 12 |
| CombiSet | Fresenius Medical Care | 11 |
| Cartridge Blood Set | Gambro Renal Products S.A. DE C.V. | 8 |
| 5008X | Fresenius Medical Care Renal Therapies Group, LLC | 7 |
| Sunder | Sunder Biomedical Tech. Co., Ltd. | 6 |
| Streamline Airless System Set with Locksite Needleless Access Sites | Medisystems Corp. | 5 |
| Tablo(R) Cartridge | Outset Medical, Inc. | 5 |
| NovaLine | Bain Medical Equipment(Guangzhou) Co., Ltd. | 5 |
| Medisystems Hemodialysis Blood Tubing Sets | Medisystems Corp. | 4 |
| Diapact® | B. Braun Medical Inc. | 4 |
Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
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.