FDA UDI
In Commercial Distribution
🇺🇸 United States
FertiCult High Viscosity Oil
DI: 05411967000487
·
Model: HVOIL100P
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FertiCult High Viscosity Oil
- Primary DI
- 05411967000487
- Version / Model
- HVOIL100P
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-28
- Public Version
- 1
- Public Version Date
- 2023-03-08
- Public Version Status
- New
- Public Device Record Key
- 3f32c94d-d3b7-4413-aba4-dae45dd33d0c
Device Description
FertiCult High Viscosity Oil - HVOIL100P (100ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oil (d=0.86-0.88g/ml) for use in In Vitro Fertilization (IVF), Intracytoplasmatic Sperm Injection (ICSI) and Assisted reproductive technologies (ART). For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com).
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 05411967001248 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 05411967000487 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 100 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from (sun)light and avoid exposure to sources of irradiation