Cartridge Blood Set
The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used…
The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight – Low Volume model is used when a low extracorporeal blood volume is recommended.
5manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | 2025-07-21 (version 8) |
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, manufacturing date |
| Storage | Storage environment temperature -18 to 49 °C; Storage environment temperature 0 to 120 °F; Special storage condition: The blood transport system must be stored in a dry place |
| Packaging | Case of 15, case of 5, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 103402 | In distribution | |
| 101025 | In distribution | |
| 101290 | In distribution | |
| 114434 | In distribution | |
| 114435 | In distribution | |
| 103401 | In distribution | |
| 106289 | In distribution | |
| 109536 | 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 |
| 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 |
| Vital | Vital Healthcare SDN. BHD. | 3 |
Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2021-04-14 | Class II | Under Investigation by firm | There is a potential leak between the venous patient connector and patient’s hemodialysis access. | 17,487 units | 2024-05-10 |
| Baxter Healthcare Corporation | UDI-DI | 2020-12-30 | Class II | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | 7437480 units | |
| Baxter Healthcare Corporation | UDI-DI | 2020-12-30 | Class II | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | 385 devices | |
| Baxter Healthcare Corporation | UDI-DI | 2020-12-30 | Class II | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | 1460 devices | |
| Baxter Healthcare Corporation | UDI-DI | 2020-12-30 | Class II | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | 211155 devices | |
| Baxter Healthcare Corporation | UDI-DI | 2020-12-30 | Class II | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | 57825 devices | |
| Baxter Healthcare Corporation | UDI-DI | 2020-12-30 | Class II | Under Investigation by firm | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | 25785 devices | |
| Baxter Healthcare Corporation | UDI-DI | 2020-04-17 | Class II | Process control | Potential disconnection of tubing set. | 2,361,885 units | 2023-02-07 |
| Baxter Healthcare Corporation | UDI-DI | 2020-04-17 | Class II | Process control | Potential disconnection of tubing set. | 53,895 units | 2023-02-07 |
| Baxter Healthcare Corporation | UDI-DI | 2020-04-17 | Class II | Process control | Potential disconnection of tubing set. | 4,065 | 2023-02-07 |
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.