6ml Syringe, NFV X SCD
6ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug , case of 25
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 | 2025-06-16 (version 5) |
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 25 |
| Distribution end date | 2024-12-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RV-T15 | Withdrawn |
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.