CombiSet
Pre-pump, 6.35 mm, low volume
5manufacturers in China registered for this device type
11catalogue 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 | Fresenius Medical Care, United States |
|---|---|
| FDA product code | FJK |
| Device type | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5820 |
| 510(k) | K962081 |
| Record published | 2015-09-24 |
| Record revised | 2019-06-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from moisture, freezing, and excessive heat |
| Packaging | Pack of 24, pack of 28, pack of 12, pack of 20 |
| Sizes | Total volume 78 to 185 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-2722-9 | Total Volume 142 ml | In distribution |
| 03-2622-3 | Total Volume 142 ml | In distribution |
| 03-2795-7 | Total Volume 151 ml | In distribution |
| 03-2742-9 | Total Volume 142 ml | In distribution |
| 03-2922-7 | Total Volume 145 ml | In distribution |
| 03-2522-1 | In distribution | |
| 03-2692-6 | Total Volume 78 ml | In distribution |
| 03-2631-4 | Total Volume 131 ml | In distribution |
| 03-2630-6 | Total Volume 136 ml | In distribution |
| 03-2696-7 | Total Volume 185 ml | In distribution |
| 03-2621-5 | Total Volume 138 ml | 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 |
| 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 |
| 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
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2010-11-19 | Not classified | Device Design | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. | 190,080 units (7920 cases x 24 units) | 2012-11-03 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2010-11-19 | Not classified | Device Design | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. | 10, 032 units (418 cases x 24 units) | 2012-11-03 |
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.