CAREline
Catalogue number 0342501, listed by Fresenius Medical Care, United States, under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
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 |
| Record published | 2018-04-17 |
| Record revised | 2024-01-10 (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 |
| Packaging | Null of 28 |
| Sizes | Total volume 126.3 ml |
| Distribution end date | 2018-04-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0342501 | Total Volume 126.3 ml | Withdrawn |
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.