V-Onestep
V-ONESTEP is a laboratory medium for culturing human embryos after fertilization through day five or six of development. It supports the in vitro culture phase of assisted reproduction. The…
V-ONESTEP is a laboratory medium for culturing human embryos after fertilization through day five or six of development. It supports the in vitro culture phase of assisted reproduction.
The medium is sterile filtered and filled into presterilized bottles. Its formulation includes physiological salts and other culture medium constituents to provide the environment used during embryo development.
Listed Item
V-ONESTEP is a medium for culturing human embryos. It is suitable for cultivation of all stages of embryo development, for use with assisted reproduction techniques (ART).
Storage Period
V-ONESTEP has a 90 day shelf life when stored at 2 to 8 degrees Celsius. An opened bottle can be used for seven days under the specified storage conditions. Its culture indication ends at the blastocyst development period described for day five or six.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Vitromed GmbH, Germany |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K193285 |
| Record published | 2022-04-04 |
| Record revised | 2023-12-04 (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 |
| Packaging | Board box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V-OSM-10 | In distribution | |
| V-OSM-20 | In distribution | |
| V-OSM-60 | In distribution | |
| V-OSM-20P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| Sydney IVF | William A. Cook Australia PTY, Ltd. | 29 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
Showing 12 of 360. All products under Media, Reproductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241833 | 2025-03-21 |
| K240176 | 2024-09-13 |
| K232125 | 2024-03-20 |
| K222606 | 2023-05-26 |
| K223117 | 2023-01-31 |
| K193285 | 2020-11-20 |
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.