Evolve Cell Culture Bag
EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing
9manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| 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 |
| Trummed Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Zhejiang Saining Biotechnology Co., Ltd. | Taizhou | Zhejiang | Manufacturer | 12 |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Suzhou Cellpro Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 6 |
Record
| Listed by | OriGen Biomedical, Inc., United States |
|---|---|
| FDA product code | KJA |
| Device type | Flask, Tissue Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.2240 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-18 |
| Record revised | 2026-01-26 (version 2) |
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 |
| Storage | Special storage condition: Keep Dry; Special storage condition: Do not re-use; Special storage condition: Do not use if package is damaged; Special storage condition: Do not resterilize |
| Packaging | Carton of 20 |
| Distribution end date | 2026-01-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EV120 + F-M12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Corning | Corning Incorporated | 432 |
| Corning® PureCoat™ | Corning Incorporated | 20 |
| Falcon | Corning Incorporated | 8 |
| Evolve | OriGen Biomedical, Inc. | 4 |
| TC Flask T75,Cell+ | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Tube 10ml 97x16PS | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T75,Stand.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| PureCoat | Corning Incorporated | 1 |
| TC Flask T175,Stand.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Tube 12ml 99x16PS | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T75,Cell+,Vented Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T75,Susp.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
Showing 12 of 27. All products under Flask, Tissue Culture
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-01-28 | Class III | Labeling False and Misleading | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. | 1201 units | 2023-04-19 |
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.