FDA UDI
In Commercial Distribution
🇺🇸 United States
FertiCult Mineral Oil
DI: 05411967000883
·
Model: MINOIL500P
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FertiCult Mineral Oil
- Primary DI
- 05411967000883
- Version / Model
- MINOIL500P
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-06
- Public Version
- 3
- Public Version Date
- 2022-05-06
- Public Version Status
- Update
- Public Device Record Key
- 124089d8-89ca-46e0-8870-061d438a3dbe
Device Description
FertiCult™ Mineral Oil - MINOIL500P (500ml in PETG bottle) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. 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
- 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 | 05411967000883 | GS1 | ||||
| Package | 05411967001163 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 500 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight