Spike Tube Set Adapter
One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 20
12manufacturers in China registered for this device type
1catalogue number
1recall
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 | OriGen Biomedical, Inc., United States |
|---|---|
| FDA product code | KJG |
| Device type | Tube, Tissue Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2025-06-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-FFP12 | 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 |
| Custom Healthcare Systems Inc. | Manus Medical, LLC | 9 |
| 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 |
Showing 12 of 51. All products under Tube, Tissue Culture
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-12-19 | Class II | Nonconforming Material/Component | Accessory sets contain a syringes not yet qualified for the accessory’s intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes | 3613 Cases |
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.