FDA UDI
In Commercial Distribution
🇺🇸 United States
V-ONESTEP
DI: 04260650070020
·
Model: V-OSM-20P
·
VITROMED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- V-ONESTEP
- Primary DI
- 04260650070020
- Version / Model
- V-OSM-20P
- Catalog Number
- V-OSM-20P
- Company Name
- VITROMED GmbH
- Labeler DUNS
- 315234102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-05
- Public Version
- 2
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 369898ad-52bd-49d9-8547-91e0117f142a
Device Description
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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44046 | IVF medium | A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260650070020 | GS1 | ||||
| Package | 04260650071720 | GS1 | Board box | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193285 | 000 |