Medline
STR KIT BCT REV A BCT # 514001026 108/CS
12manufacturers in China registered for this device type
184catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Hubei (2), Fujian (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Anji Fang Yuan Sanitary Material Co., Ltd. | Anji | Zhejiang | Repacker / relabeller | 13 |
| Shandong Succare Medical Co., Ltd. | Zibo | Shandong | Manufacturer | 12 |
| Ayida (Xiamen) P&C Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 8 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Premarket notification | Exempt |
| Record published | 2016-10-14 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 40, pack of 20, pack of 28, pack of 30, case of 20, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNDC1666A | In distribution | |
| DYNDC2543 | In distribution | |
| DYNDC1627A | In distribution | |
| DYNDBARD1 | In distribution | |
| DYNDC1460 | In distribution | |
| DYNDC1939 | In distribution | |
| DYNDC2189B | In distribution | |
| DYNDC1892 | In distribution | |
| DYNDBARD29 | In distribution | |
| DYNDC1599A | In distribution | |
| P849032 | In distribution | |
| DYNDC1519A | In distribution | |
| DYNDC2543 | In distribution | |
| DYND75226 | In distribution | |
| DYNDC1842A | In distribution | |
| DYNDC1301B | In distribution | |
| DYNDC1267D | In distribution | |
| ATT1984 | In distribution | |
| DYNDC2543 | In distribution | |
| DYNDC1915 | In distribution | |
| DYNDC1471 | In distribution | |
| DYNDC1163B | In distribution | |
| DYNDC2235 | In distribution | |
| P392929 | In distribution | |
| DYNDC1315B | In distribution | |
| DYNDBARDG26 | In distribution | |
| DYNDC1973B | In distribution | |
| DYNDC1585C | In distribution | |
| DYNDC2246 | In distribution | |
| DYNDC1901 | In distribution | |
| DYNDC2189A | In distribution | |
| DYNDC2006A | In distribution | |
| DYKD1087382W1 | In distribution | |
| BH102BM2 | In distribution | |
| DYNDBARDG24 | In distribution | |
| DYNDC1458 | In distribution | |
| DYNDC1738 | In distribution | |
| DYNDBARDG27 | In distribution | |
| DYNDC1242 | In distribution | |
| DYNDC1937NS | In distribution | |
| DYNDC1532 | In distribution | |
| DYNDC2203 | In distribution | |
| DYNDC1870 | In distribution | |
| DYNDC1550 | In distribution | |
| DYNDBARD3 | In distribution | |
| DYND75223 | In distribution | |
| DYNDL1578A | In distribution | |
| DYNDC1747 | In distribution | |
| DYND75235 | In distribution | |
| DYNDC1675 | In distribution | |
| DYNDL1177C | In distribution | |
| DYNDC1810 | In distribution | |
| P948343 | In distribution | |
| DYNDC1665 | In distribution | |
| DYNDL1377 | In distribution | |
| DYNDBARDG32 | In distribution | |
| DYNDBARDG33 | In distribution | |
| DYNDC1634 | In distribution | |
| DYNDC2257 | In distribution | |
| DYNDC1863 | In distribution | |
| DYNDC1186A | In distribution | |
| DYNDC2744 | In distribution | |
| DYNDC2227 | In distribution | |
| DYNDC1701 | In distribution | |
| DYNDBARDG29 | In distribution | |
| DYNDC2229 | In distribution | |
| DYNDC2181A | In distribution | |
| DYNDA1146 | In distribution | |
| DYNDC1677 | In distribution | |
| P946439 | In distribution | |
| DYNDC1781 | In distribution | |
| DYNDC2063B | In distribution | |
| DYNDBARD18 | In distribution | |
| DYNDG1015E | In distribution | |
| DYNDC1864 | In distribution | |
| DYNDC1243A | In distribution | |
| DYNDC1495C | In distribution | |
| P949389 | In distribution | |
| DYNDC2251 | In distribution | |
| M101320 | In distribution | |
| DYNDC1283B | In distribution | |
| DYND75230 | In distribution | |
| DYK1101835CV | In distribution | |
| DYNDC1851 | In distribution | |
| DYND75224 | In distribution | |
| DYNDC2223 | In distribution | |
| DYND75233 | In distribution | |
| DYNDC1265A | In distribution | |
| DYND75227 | In distribution | |
| DYNDC1161A | In distribution | |
| DYNDBARDG25 | In distribution | |
| DYNDC1236 | In distribution | |
| P964168 | In distribution | |
| DYNDC1491 | In distribution | |
| DYNDC1654 | In distribution | |
| DYNDC1134 | In distribution | |
| DYNDC1127A | In distribution | |
| DYNDC1305A | In distribution | |
| MSCKIT01 | In distribution | |
| DYNDC1356B | In distribution | |
| DYNDC1279 | In distribution | |
| DYNDC1774A | In distribution | |
| PHS110170A | In distribution | |
| DYNJ07466A | In distribution | |
| DYND74661 | In distribution | |
| DYNDC1595A | In distribution | |
| DK7-0114LF | In distribution | |
| DYNDC1799 | In distribution | |
| DYNDC2583 | In distribution | |
| DYNDC2083B | In distribution | |
| DYNDC1639C | In distribution | |
| DYNDC2181 | In distribution | |
| DYNDC1497 | In distribution | |
| DYNDC1725A | In distribution | |
| DYNDC1316A | In distribution | |
| DYNDC1699 | In distribution | |
| DYNDBARDG28 | In distribution | |
| DYNDC1475A | In distribution | |
| DYNDL1250B | In distribution | |
| DYNDW1016A | In distribution | |
| DYNDC2881 | In distribution | |
| DYND06002 | In distribution | |
| DYNDBARD11A | In distribution | |
| DYNDL1528A | In distribution | |
| DYNDC2244 | In distribution | |
| DYNDC1198B | In distribution | |
| DYNDC2201 | In distribution | |
| P791011 | In distribution | |
| DYNDC1871 | In distribution | |
| DYNDBARDG23 | In distribution | |
| ATTDCBAP | In distribution | |
| DYNDC1456A | In distribution | |
| DYNDC2582A | In distribution | |
| DYND75222 | In distribution | |
| DYNDC1887 | In distribution | |
| DYNDBARD21 | In distribution | |
| P109259 | In distribution | |
| DYNDC1412 | In distribution | |
| DYNJ03333 | In distribution | |
| DYNDC1651 | In distribution | |
| DYNDC1850 | In distribution | |
| DYNDC1282A | In distribution | |
| DYNDC2582A | In distribution | |
| DYNDC1849 | In distribution | |
| DYND75234 | In distribution | |
| DYNDC1624 | In distribution | |
| DYNDC1931 | In distribution | |
| DYNDC1410 | In distribution | |
| DYKM1119 | In distribution | |
| DYND75231 | In distribution | |
| DYNDC1662 | In distribution | |
| DYNDC1778A | In distribution | |
| DYNDC2182A | In distribution | |
| DYNDC1732 | In distribution | |
| DYNDCA1008A | In distribution | |
| DYNDC2215 | In distribution | |
| DYNDC1109B | In distribution | |
| DYNDC1213 | In distribution | |
| DYNDC1524 | In distribution | |
| DYNDC1681A | In distribution | |
| DYNDC2258 | In distribution | |
| DYNDC1542B | In distribution | |
| DYNDC2006B | In distribution | |
| DYNDC2130B | In distribution | |
| DYNDC2167 | In distribution | |
| DYNDBARDG22 | In distribution | |
| DYNDC2228 | In distribution | |
| DYNDL1151B | In distribution | |
| DYND74771 | In distribution | |
| DYNDC1565A | In distribution | |
| DYNDC2474 | In distribution | |
| DYNDC1884 | In distribution | |
| DYNDC1539 | In distribution | |
| DYND75229 | In distribution | |
| DYNDC1844 | In distribution | |
| P818377 | In distribution | |
| DYNDC1689A | In distribution | |
| DYNDC1556 | In distribution | |
| DYNDC1540 | In distribution | |
| DYNDC1523B | In distribution | |
| DYNDC1848 | In distribution | |
| DYNDC1861 | In distribution | |
| DYNDC2007A | In distribution | |
| DYNDC1886A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 1,221 |
| Stradis Medical, LLC. | Stradis Healthcare | 116 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 24 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 15 |
| Wound CareKit | Mirodx, LLC | 12 |
| LSL Healthcare | Lsl Industries, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| carePAC | Extremity Care | 11 |
| Medical Action Industries | Medical Action Industries, Inc. | 8 |
| Curaplex | Bound Tree Medical, LLC | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
Showing 12 of 25. All products under Wound Dressing Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2023-11-15 | Class I | Nonconforming Material/Component | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse As | 72,624 units |
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.