FDA UDI
In Commercial Distribution
🇺🇸 United States
V-OIL
DI: 04260650071232
·
Model: V-OIL-100G
·
VITROMED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- V-OIL
- Primary DI
- 04260650071232
- Version / Model
- V-OIL-100G
- Catalog Number
- V-OIL-100G
- Company Name
- VITROMED GmbH
- Labeler DUNS
- 315234102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-04
- Public Version
- 1
- Public Version Date
- 2022-04-12
- Public Version Status
- New
- Public Device Record Key
- 084fa4a4-2e5b-420a-a228-1feaabe7a2f1
Device Description
V-OIL is a ready-to-use pre-washed, light paraffin oil for use as an overlay for culture of gametes, zygotes, or embryos in Assisted Reproduction Technology (ART) and micro-manipulation procedure to prevent the evaporation of water and protects the media against changes in osmolality and pH. Culture of embryos in small volumes of medium under oil helps to enhance rates of embryonic development.
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
- Yes
- 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 |
|---|---|---|---|---|
| QKI | Media, Reproductive, Exempt | 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 | 04260650071232 | GS1 | ||||
| Package | 04260650070532 | GS1 | Board box | 1 | In Commercial Distribution |