Custom Healthcare Systems Inc.
9 catalogue numbers from D8-10601, listed by Manus Medical, LLC, United States, under Tube, Tissue Culture. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (5), Liaoning (1). 2 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 |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| 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 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian | Liaoning | Contract manufacturer | 15 |
| Suzhou Cnnc Huadong Radiation Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Zhejiang Saining Biotechnology Co., Ltd. | Taizhou | Zhejiang | Manufacturer | 12 |
Record
| Listed by | Manus Medical, LLC, United States |
|---|---|
| FDA product code | KJG |
| Device type | Tube, Tissue Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-27 |
| 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 |
| Label carries | lot or batch number, expiry date |
| Packaging | N/a of 100, n/a of 50, n/a of 25, pack of 110, na of 200 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D8-10601 | In distribution | |
| D8-16156 | In distribution | |
| R1186 / 12880 | In distribution | |
| UNC-10000 | In distribution | |
| D6-16619 | In distribution | |
| B9-19066 | In distribution | |
| B9-19462 | In distribution | |
| D8-10610 | In distribution | |
| D8-16150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 32 |
| Accessories | OriGen Biomedical, Inc. | 18 |
| Spike Adapter | OriGen Biomedical, Inc. | 14 |
| LabChoice Culture Tubes, With Dual Position Cap, Polystyrene, 17 x 100 mm | Dynarex Corp. | 7 |
| TubeSet Adapter | OriGen Biomedical, Inc. | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Injection Spike | OriGen Biomedical, Inc. | 3 |
| Accessory Sets | OriGen Biomedical, Inc. | 3 |
| Accessory Set | OriGen Biomedical, Inc. | 3 |
| Female to Female Adapter | OriGen Biomedical, Inc. | 2 |
| 3ml Syringe, FLL X SCD | OriGen Biomedical, Inc. | 2 |
| O-Wrap | OriGen Biomedical, Inc. | 2 |
Showing 12 of 51. All products under Tube, Tissue Culture
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.