FDA UDI
In Commercial Distribution
🇺🇸 United States
ARTSMedia High Viscosity Oil (AM-HV Oil)
DI: 05745000591022
·
Model: 50 ml
·
Artsmedia Denmark ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARTSMedia High Viscosity Oil (AM-HV Oil)
- Primary DI
- 05745000591022
- Version / Model
- 50 ml
- Catalog Number
- 506050
- Company Name
- Artsmedia Denmark ApS
- Labeler DUNS
- 306267547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-22
- Public Version
- 1
- Public Version Date
- 2024-01-30
- Public Version Status
- New
- Public Device Record Key
- 921f6b12-8d48-44e8-975a-de9adb29ff4c
Device Description
"AM-HV Oil is a high viscosity mineral oil (d=0.86-0.88g/ml) pre-washed with ultra pure water for use in In Vitro Fertilization (IVF), Intracytoplasmic Sperm Injection (ICSI) and assisted reproductive technologies (ART). The oil permits small volumes of medium to be used for fertilization and embryo culture / handling. The oil overlay prevents media evaporation, which would result in increased osmolarity, and to avoid fluctuations in the pH and the temperature. "
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
- 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 | 05745000591022 | GS1 |