Medline
IV ADMINSET,15DR,3 Splitseptm PORTS,109"
49manufacturers in China registered for this device type
148catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| 510(k) | K151991 |
| Record published | 2022-12-02 |
| Record revised | 2022-01-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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, manufacturing date |
| Storage | Special storage condition: Avoid freezing or excessive heat |
| Packaging | Case of 100, box of 25, case of 50, pack of 50, case of 4 |
| Sizes | Length 0.375 to 0.75 in; needle gauge 21 to 26 G; weight 21 to 25 g |
| Distribution end date | 2026-01-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDTA1540 | In distribution | |
| DYNDTN1539 | In distribution | |
| DYNDST1545 | In distribution | |
| 945638174 | In distribution | |
| DYNDTN1845 | In distribution | |
| OGBCS23GT | In distribution | |
| DYNDTNHBC23G | Length 0.75 in | In distribution |
| 941300032 | In distribution | |
| DYNDTN2006 | In distribution | |
| 949000114 | In distribution | |
| DYNDTN1812 | In distribution | |
| DYNDST1512 | In distribution | |
| DYNDTN2516 | In distribution | |
| DYNDTN0080 | In distribution | |
| DYNDTN1530 | In distribution | |
| 949000222 | In distribution | |
| DYNDTN2524 | In distribution | |
| 945638137 | In distribution | |
| DYNDTN0009 | In distribution | |
| 949000192 | In distribution | |
| DYNDTN0601ACS | In distribution | |
| DYNDTN1522 | In distribution | |
| DYNDTNBC23G7 | In distribution | |
| DYNDNP1435 | In distribution | |
| OGBCS23GL | In distribution | |
| DYTC1301509 | In distribution | |
| 946638110 | In distribution | |
| DYNDNP1436 | In distribution | |
| DYTC1429524 | In distribution | |
| 949000221 | In distribution | |
| 945638095 | In distribution | |
| DYTC1172567 | In distribution | |
| 949000112 | In distribution | |
| DYNDTN1523 | In distribution | |
| DYNDTC5082 | In distribution | |
| DYNDA1406 | In distribution | |
| DYNDTNBCS21G | In distribution | |
| DYNDTA1530 | In distribution | |
| DYNDTNBCS23G | In distribution | |
| 945638152 | In distribution | |
| DYNDTN1003 | In distribution | |
| DYNDTC5077 | In distribution | |
| DYNDTN1529 | In distribution | |
| DYNDTB1002 | In distribution | |
| 949000224 | In distribution | |
| DYNDTA1812 | In distribution | |
| DYNDTNBC21GL | Needle Gauge 21 G | In distribution |
| 940438285 | In distribution | |
| DYNDTN1516 | In distribution | |
| DYNDTNHBC25G | Needle Gauge 25 G | In distribution |
| 949000057 | In distribution | |
| DYNDTC2000A | In distribution | |
| DYNDTN1537 | In distribution | |
| 949000056 | In distribution | |
| DYNDTNHBC21G | Needle Gauge 21 G | In distribution |
| 949000113 | In distribution | |
| OGBCS25GL | In distribution | |
| 948838075 | In distribution | |
| DYNDTC5081 | In distribution | |
| 949000190 | In distribution | |
| DYNDTN1512B | In distribution | |
| 945638145 | In distribution | |
| 910029203 | In distribution | |
| 949000191 | In distribution | |
| DYNDTN0555 | In distribution | |
| DYNDTN1512 | In distribution | |
| OGBCS21G | In distribution | |
| DYTC1382095A | In distribution | |
| DYNDTN1538 | In distribution | |
| DYNDTNBC21G7 | In distribution | |
| DYNDTN0512 | In distribution | |
| DYNDTN0001 | In distribution | |
| DYNDTN2521 | In distribution | |
| DYNDTC5081B | In distribution | |
| DYNDTNBC23GL | Length 0.75 in | In distribution |
| DYNDTC5002 | In distribution | |
| 949300228 | In distribution | |
| OGBCS23G | In distribution | |
| DYNDTN2512 | In distribution | |
| OGBCS21GT | In distribution | |
| DYNDTN1603 | In distribution | |
| 940445254 | In distribution | |
| 948838076 | In distribution | |
| OGBCS25G | In distribution | |
| SYRA101261 | Needle Gauge 26 G | In distribution |
| 949000227 | In distribution | |
| 946638111 | In distribution | |
| DYNDTN1545 | In distribution | |
| OGBCS25G7 | In distribution | |
| OGBCS25GT | In distribution | |
| DYNDTN1002 | In distribution | |
| 949000226 | In distribution | |
| DYNDTN0007 | In distribution | |
| OGBCS21GL | In distribution | |
| DYNDTB1603 | In distribution | |
| DYNDTA2006 | In distribution | |
| DYNDTN0004 | In distribution | |
| DYNDTN1829 | In distribution | |
| DYNDTN1545D | In distribution | |
| DYNDTN1536 | In distribution | |
| DYNDTN1540A | In distribution | |
| DYNDTNBC25GL | Weight 25 g | In distribution |
| DYNDTN0003 | In distribution | |
| DYNDNP1437 | In distribution | |
| 949000223 | In distribution | |
| DYNDNP1438 | In distribution | |
| 940438325 | In distribution | |
| DYNDTN1545L | In distribution | |
| 949000225 | In distribution | |
| 949000040 | In distribution | |
| DYNDTN2522 | In distribution | |
| DYTC1307763 | In distribution | |
| 949000228 | In distribution | |
| 948807146 | In distribution | |
| DYTC1320239 | In distribution | |
| OGBCS23G7 | In distribution | |
| 945638144 | In distribution | |
| DYNDTNV200 | In distribution | |
| OGBCS21G7 | In distribution | |
| DYNDTN0529 | In distribution | |
| DYNDTNBCS25G | In distribution | |
| 940427059 | In distribution | |
| DYNDTN2001 | In distribution | |
| DYNDTNBC25G7 | In distribution | |
| 940429019 | In distribution | |
| DYNDTB2012 | Withdrawn | |
| DYNDTB2022 | Withdrawn | |
| DYNDTB2524 | Withdrawn | |
| DYNDTB1012 | Withdrawn | |
| DYNDTB1045 | Withdrawn | |
| DYNDTB0555 | Withdrawn | |
| DYNDTB2029 | Withdrawn | |
| DYNDTB1539 | Withdrawn | |
| DYNDTB1530 | Withdrawn | |
| DYNDTB1537 | Withdrawn | |
| DYNDTB1022 | Withdrawn | |
| DYNDTB5077 | Withdrawn | |
| DYNDTB1512 | Withdrawn | |
| DYNDTB2045 | Withdrawn | |
| DYNDTB1540 | Withdrawn | |
| DYNDTB1029 | Withdrawn | |
| DYNDTB1545D | Withdrawn | |
| DYNDTB1529 | Withdrawn | |
| DYNDTB0529 | Withdrawn | |
| DYNDTB5081 | Withdrawn | |
| DYNDTB1516 | Withdrawn | |
| DYNDTB0512 | Withdrawn | |
| DYNDTB1545 | Withdrawn |
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 |
| Centurion | Centurion Medical Products Corporation | 145 |
| Alaris | BD Switzerland Sàrl | 122 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170002 | 2017-09-19 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-31 | Class II | Process control | Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in | 926,227 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2024-12-16 | Class I | Under Investigation by firm | Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber. | 13,600 units | |
| Carefusion | 510(k) number | 2021-08-02 | Class II | Process control | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required | 24,360 | |
| Becton, Dickinson & Co. | 510(k) number | 2019-03-05 | Class II | Under Investigation by firm | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product. | 21220 total cases of 20 | 2020-07-15 |
| Becton, Dickinson & Co. | 510(k) number | 2019-03-05 | Class II | Under Investigation by firm | The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product. | 21220 total cases of 20 | 2020-07-15 |
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.