Zyno
BX Administration Primary Set: 105" 2 NF Y-Site, 1 Above, 1 Below Pump, .22 Filter, Back Check-Valve, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration…
BX Administration Primary Set: 105″ 2 NF Y-Site, 1 Above, 1 Below Pump,.22 Filter, Back Check-Valve, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP.
49manufacturers in China registered for this device type
35catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | Zyno Medical LLC., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K132841 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
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 | Pack of 6, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A2-80072-F | 50 | In distribution | |
| AX-80071-D | In distribution | ||
| AX-80071-P | In distribution | ||
| A2-80071-P | 50 | In distribution | |
| B2-70071-DF | 50 | In distribution | |
| B2-70071-D | 50 | In distribution | |
| BX-70071-DF | In distribution | ||
| BX-70071-D | In distribution | ||
| B2-70070 | 50 | In distribution | |
| FE01 | In distribution | ||
| AX-80071-DF | In distribution | ||
| A2-80071-PF | 50 | In distribution | |
| B2-70071-DF120 | 50 | In distribution | |
| BX-70071-DF-120 | In distribution | ||
| AX-80075 | In distribution | ||
| B2-70071-P | 50 | In distribution | |
| AA-80075 | In distribution | ||
| A2-80071-D | 50 | In distribution | |
| BX-70072 | In distribution | ||
| A2-80075 | 50 | In distribution | |
| AX-80072 | In distribution | ||
| AX-80071-PF | In distribution | ||
| AX-80071-DF-120 | In distribution | ||
| A2-80071-DF120 | 50 | In distribution | |
| FE04 | In distribution | ||
| AX-80072-F | In distribution | ||
| AX-80070 | In distribution | ||
| B2-70072 | 50 | In distribution | |
| BX-70071-P | In distribution | ||
| BX-70070 | In distribution | ||
| BX-70072-F | In distribution | ||
| A2-80071-DF | 50 | In distribution | |
| A2-80072 | 50 | In distribution | |
| B2-70072-F | 50 | In distribution | |
| A2-80070 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132841 | 2014-01-23 |
| K120685 | 2012-09-07 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Zyno Medical LLC. | 510(k) number | 2019-05-29 | Class II | Process control | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of deliverin | 354 cases (50/case)=17700 | 2020-06-22 |
| Zyno Medical LLC. | 510(k) number | 2019-05-29 | Class II | Process control | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of deliverin | 360 cases (50/case)=18,000 | 2020-06-22 |
| Zyno Medical LLC. | 510(k) number | 2016-07-29 | Class II | Process control | Administration Set potential filter leaking | 114081 sets | 2017-07-11 |
| Zyno Medical LLC. | 510(k) number | 2016-07-29 | Class II | Process control | Administration Set potential filter leaking | 78069 sets | 2017-07-11 |
| Zyno Medical LLC. | 510(k) number | 2016-07-29 | Class II | Process control | Administration Set potential filter leaking | 78063 sets | 2017-07-11 |
| Zyno Medical LLC. | 510(k) number | 2016-07-29 | Class II | Process control | Administration Set potential filter leaking | 47989 sets | 2017-07-11 |
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.