Custom Healthcare Systems Inc.
70 catalogue numbers from D6-310, listed by Manus Medical, LLC, United States, under Applicator, Absorbent Tipped, Sterile. 100 manufacturers in China are registered for this product code.
100manufacturers in China registered for this device type
70catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Zhejiang (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Bandex Industrial Corp. | Zhuhai | Guangdong | Contract manufacturer | 14 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Anqing Jiaxin Medical Technology Co., Ltd. | Anqing | Anhui | Contract manufacturer | 11 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Changzhou Hongtai Paper Film Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 100. All 100 manufacturers in China registered for Applicator, Absorbent Tipped, Sterile
Record
| Listed by | Manus Medical, LLC, United States |
|---|---|
| FDA product code | KXG |
| Device type | Applicator, Absorbent Tipped, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6025 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-26 |
| Record revised | 2023-06-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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, serial number |
| Packaging | N/a of 50, n/a of 100, n/a of 25, n/a of 20, n/a of 24, n/a of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D6-310 | In distribution | |
| BTPS FLUSH 01 | In distribution | |
| R1631 | In distribution | |
| B9-19811 | In distribution | |
| R1112B | In distribution | |
| D6-6553 | In distribution | |
| D4-324SCP | In distribution | |
| R1964 | In distribution | |
| UNC-9475 | In distribution | |
| D14-32C | In distribution | |
| R1903 | In distribution | |
| D4-425 | In distribution | |
| UNC-9472 | In distribution | |
| D14-83100 | In distribution | |
| D6-15955 | In distribution | |
| R1176 | In distribution | |
| D14-10838 | In distribution | |
| D14-9863 | In distribution | |
| B9-19853 | In distribution | |
| B9-19702 | In distribution | |
| D6-15954 | In distribution | |
| D6-11242 | In distribution | |
| R1394 | In distribution | |
| B9-18948 | In distribution | |
| D4-625 | In distribution | |
| B9-19810 | In distribution | |
| D6-19182 | In distribution | |
| UNC-10002 | In distribution | |
| D6-10809 | In distribution | |
| R1250 | In distribution | |
| R1174 | In distribution | |
| YMCP-TCRS03 | In distribution | |
| UVA-19787 | In distribution | |
| R1164 | In distribution | |
| A3-7696 | In distribution | |
| BTPS 101 | In distribution | |
| D36-7520 | In distribution | |
| JBV005 | In distribution | |
| D6-610 | In distribution | |
| YMCP-TCRS01 | In distribution | |
| D6-14944 | In distribution | |
| R1178 | In distribution | |
| R1306 | In distribution | |
| D4-624SCP | In distribution | |
| UNC-10579 | In distribution | |
| D22-6 | In distribution | |
| D4-225 | In distribution | |
| UVA-19787 | In distribution | |
| UFK-16076 | In distribution | |
| KM5075 | In distribution | |
| D2-5MC | In distribution | |
| D6-650 | In distribution | |
| R1168 | In distribution | |
| KM5073 | In distribution | |
| R1170 | In distribution | |
| D2-10472 | In distribution | |
| D22-4 | In distribution | |
| R1632 | In distribution | |
| YMCP-TCRS02 | In distribution | |
| B9-19797 | In distribution | |
| D6-350 | In distribution | |
| D14-9164 | In distribution | |
| KM5074 | In distribution | |
| D4-424SCP | In distribution | |
| R1312 | In distribution | |
| D4-325 | In distribution | |
| UNC-10580 | In distribution | |
| D6-11243 | In distribution | |
| D4-6MCV | In distribution | |
| D21-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HanHeng | Jiangsu Hanheng Medical Technology Co., Ltd. | 188 |
| Puritan | Puritan Medical Products Company LLC | 68 |
| FLOQSwabs® | Copan Italia | 54 |
| Puritan HydraFlock | Puritan Medical Products Company LLC | 39 |
| Specimen Collection Swab | HLB Co., Ltd. Healthcare | 38 |
| DeRoyal | Deroyal Industries, Inc. | 31 |
| Puritan PurFlock Ultra | Puritan Medical Products Company LLC | 29 |
| iClean | Huachenyang(Shenzhen)Technology Co., Ltd. | 28 |
| DHI Specimen Collection System | Diagnostic Hybrids, Inc. | 27 |
| National Hospital Packaging | Surgi-Pak, Inc. | 27 |
| Dryswab | Medical Wire & Equipment Company (Bath), Ltd. | 26 |
| CLASSIQSwabs™ | Copan Italia | 22 |
Showing 12 of 134. All products under Applicator, Absorbent Tipped, Sterile
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.