ICU Medical
130" (330 cm) Y-Type Blood Set w/170 Micron Filter, 2 Y-Connectors w/Check Valves, Remv 3 Gang 1o2™ Manifold, Check Valve, Rotating Luer, 1 Ext
5manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
1recall
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 | ICU Medical, Inc, 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 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K983559 |
| Record published | 2017-04-18 |
| Record revised | 2021-04-07 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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, serial number |
| Packaging | Pack of 25, case of 25, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B90038 | In distribution | |
| B9695 | In distribution | |
| Z0929 | In distribution | |
| B9756 | In distribution | |
| B90041 | In distribution | |
| B90039 | In distribution | |
| Z1278 | In distribution | |
| B9290 | In distribution | |
| B5157 | In distribution | |
| Z3521 | In distribution | |
| B9698 | In distribution | |
| B9772 | In distribution | |
| Z3550 | In distribution | |
| Z3267 | In distribution | |
| Z1340 | In distribution | |
| B99125 | In distribution | |
| B9359 | In distribution | |
| Z0916 | In distribution | |
| B9357 | In distribution | |
| Z1646 | In distribution | |
| B9282 | In distribution | |
| Z3076 | In distribution | |
| Z1689 | In distribution | |
| B90028 | In distribution | |
| B90065 | In distribution | |
| Z3465 | In distribution | |
| MC9011 | In distribution | |
| Z0750 | In distribution | |
| Z0877 | In distribution | |
| MC33921 | In distribution | |
| B3232 | In distribution | |
| 46114-35 | In distribution | |
| Z3249 | In distribution | |
| B9751 | In distribution | |
| Z2684 | In distribution | |
| B9740 | In distribution | |
| B9220 | In distribution | |
| B9757 | In distribution | |
| B9622 | In distribution | |
| B9211 | In distribution | |
| B9309 | In distribution | |
| B9752 | In distribution | |
| Z3294 | In distribution | |
| Z3172 | In distribution | |
| Z1440 | In distribution | |
| Z3131 | In distribution | |
| B3278 | In distribution | |
| Z3075 | In distribution | |
| B9900-639 | In distribution | |
| Z0878 | In distribution | |
| B9405 | In distribution | |
| B9449 | In distribution | |
| Z1203 | In distribution | |
| B9561 | In distribution | |
| B5156 | In distribution | |
| Z3417 | In distribution | |
| B9391 | In distribution | |
| Z2795 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Vital | Vital Healthcare SDN. BHD. | 3 |
Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983559 | 1998-12-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2020-08-31 | Class II | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patie | 2900 |
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.