FDA UDI
In Commercial Distribution
🇺🇸 United States
V-VITFREEZE
DI: 04260650070327
·
Model: V-FS-KIT
·
VITROMED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- V-VITFREEZE
- Primary DI
- 04260650070327
- Version / Model
- V-FS-KIT
- Company Name
- VITROMED GmbH
- Labeler DUNS
- 315234102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-10-16
- Public Version
- 1
- Public Version Date
- 2024-10-24
- Public Version Status
- New
- Public Device Record Key
- 0132d66a-f172-45e9-88c4-c5768936acb5
Device Description
V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Technology (ART). There are in total 3 vials of pink solutions in the package: -1 vial of Equilibration Solution (ES), with a blue cap and label. - 2 vials of Vitrification Solution (VS), with green caps and labels. V-VITFREEZE is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04260650070273 | GS1 | ||||
| Primary | 04260650070327 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240176 | 000 |