Medline Industries, Inc.
SET Admin 72IN N0 Vent NO Filt
49manufacturers in China registered for this device type
118catalogue 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) | K003225 |
| Record published | 2016-11-07 |
| Record revised | 2025-03-31 (version 10) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12, case of 6, case of 15, case of 150, case of 50, case of 200 |
| Distribution end date | 2021-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYK1066128A2 | In distribution | |
| P586052A | In distribution | |
| P410010 | In distribution | |
| DYKA1161 | In distribution | |
| DYK1023571A4 | In distribution | |
| DYNJZ92526A | In distribution | |
| DYKA1091 | In distribution | |
| DYKA1373 | In distribution | |
| DYKA1231 | In distribution | |
| P286007 | In distribution | |
| PHS4961003 | In distribution | |
| P411607 | In distribution | |
| DYKM1278B | In distribution | |
| P554546 | In distribution | |
| DYNDH1184 | In distribution | |
| DYNJZ35003A | In distribution | |
| ACC010276A | In distribution | |
| DYKA1321A | In distribution | |
| DYKA1192 | In distribution | |
| ACC010276B | In distribution | |
| DYKA1126A | In distribution | |
| DYNJ56985 | In distribution | |
| PHS200845004 | In distribution | |
| DYKA1296A | In distribution | |
| DYKA1181 | In distribution | |
| DYKA1009 | In distribution | |
| DYKA1346B | In distribution | |
| DYNDA1653 | In distribution | |
| DYKA1157 | In distribution | |
| DYNDH1171A | In distribution | |
| DYNJZ35004A | In distribution | |
| DYKA1000D | In distribution | |
| DYKM1278A | In distribution | |
| DYKA1182A | In distribution | |
| PHS269765003 | In distribution | |
| DYKA1165 | In distribution | |
| P265033 | In distribution | |
| DYKA1168 | In distribution | |
| P857834 | In distribution | |
| DYK1271239A | In distribution | |
| DYKA1389 | In distribution | |
| DYK1005503A1 | In distribution | |
| DYKA1198 | In distribution | |
| DYNDA3171 | In distribution | |
| DYNJ14083C | In distribution | |
| DYKA1152A | In distribution | |
| DYK1039275A2 | In distribution | |
| PHS254758002 | In distribution | |
| DYKA1044A | In distribution | |
| DYKA1145 | In distribution | |
| DYK1010391A3 | In distribution | |
| DYKA1182 | In distribution | |
| DYKA1217 | In distribution | |
| DYKA1237 | In distribution | |
| DYKA1173 | In distribution | |
| DYKA1001 | In distribution | |
| SAMPC0136 | In distribution | |
| DYKA1117 | In distribution | |
| DYKA1170 | In distribution | |
| DYKA1062C | In distribution | |
| DYKA1062B | In distribution | |
| P4768A | In distribution | |
| DYKA1119A | In distribution | |
| DYKA1128 | In distribution | |
| DYKA1278 | In distribution | |
| DYNJ53133 | In distribution | |
| DYKA1187 | In distribution | |
| DYKA1142A | In distribution | |
| DYNJ0796184D | In distribution | |
| DYKA1171A | In distribution | |
| DYKA1238A | In distribution | |
| DYKM1278 | In distribution | |
| DYKA1075A | In distribution | |
| DYKA1186 | In distribution | |
| DYNJ0796184F | In distribution | |
| DYKA1188 | In distribution | |
| DYKA1026A | In distribution | |
| DYNJLBVS108 | In distribution | |
| P854565 | In distribution | |
| DYNJRA2440 | In distribution | |
| DYKA1238 | In distribution | |
| DYKM1344A | In distribution | |
| DYK1013659A | In distribution | |
| DYNDH1186 | In distribution | |
| DYK1021517A | In distribution | |
| P508213 | In distribution | |
| DYKA1101 | In distribution | |
| DYKA1171 | In distribution | |
| VASC1053 | In distribution | |
| DYKA1240 | In distribution | |
| DYKA1158 | In distribution | |
| DYKA1014D | In distribution | |
| P895057 | In distribution | |
| PHS163703003 | In distribution | |
| DYKA1230 | In distribution | |
| DYKM1341 | In distribution | |
| DYKA1014F | In distribution | |
| BOST122922 | In distribution | |
| DYKA1096 | In distribution | |
| DYNJTBGPM06 | In distribution | |
| SAMPC0126 | In distribution | |
| DNSC17807 | In distribution | |
| DYKA1235 | In distribution | |
| DYNJ56985A | In distribution | |
| DYKA1202 | In distribution | |
| DYKA1188A | In distribution | |
| PACH1054 | In distribution | |
| DYKA1231B | In distribution | |
| DYNDA2944 | In distribution | |
| DYK1066551A1 | In distribution | |
| DYKS1161A | In distribution | |
| DYKD1000915A | In distribution | |
| DYKA1218 | In distribution | |
| DYKA1354 | In distribution | |
| DYKL1419 | In distribution | |
| P686330 | In distribution | |
| DYNJTBGPM84 | In distribution | |
| DYKM1344C | 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 |
| 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 |
|---|---|
| K170002 | 2017-09-19 |
Recalls Naming This Product
23 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 |
|---|---|---|---|---|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | 510(k) number | 2021-10-28 | Class II | Employee error | This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set. | 620 tube sets | 2023-08-07 |
| Baxter Healthcare Corporation | 510(k) number | 2019-12-12 | Class II | Device Design | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. | 271,014,984 units | |
| Baxter Healthcare Corporation | 510(k) number | 2019-12-12 | Class II | Device Design | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. | 43,495,400 units | |
| Baxter Healthcare Corporation | 510(k) number | 2011-12-06 | Not classified | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. | 4,560 units | 2012-11-01 |
| Baxter Healthcare Corporation | 510(k) number | 2011-07-21 | Not classified | Employee error | The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded i | 4,752 units | 2012-06-18 |
| Baxter Healthcare Corporation | 510(k) number | 2010-09-09 | Not classified | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. | 72,136 sets | 2011-09-07 |
| Baxter Healthcare Corporation | 510(k) number | 2010-09-09 | Not classified | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. | data not available | 2011-09-07 |
| Baxter Healthcare Corporation | 510(k) number | 2007-02-16 | Not classified | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. | 480 units | 2008-03-17 |
| Baxter Healthcare Corporation | 510(k) number | 2005-12-15 | Not classified | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. | 29,200 sets | 2008-08-18 |
| Baxter Healthcare Corporation | 510(k) number | 2005-12-15 | Not classified | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. | 4,848 sets | 2008-08-18 |
| Baxter Healthcare Corporation | 510(k) number | 2005-12-15 | Not classified | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. | 35,520 sets | 2008-08-18 |
| Baxter Healthcare Corporation | 510(k) number | 2005-02-28 | Not classified | Other | Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve. | 1,171,116 sets | 2007-02-08 |
| Baxter Healthcare Corporation | 510(k) number | 2004-04-28 | Not classified | Other | Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device. | 29,425,708 sets | 2007-02-08 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 471,460 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 3,456 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 887,483 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 43,440 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 11,280 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 340,426 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 86,547 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 12,480 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 71,041 units | 2004-06-29 |
| Baxter Healthcare Corporation | 510(k) number | 2003-07-16 | Not classified | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. | 299,839 units | 2004-06-29 |
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.