FDA UDI
In Commercial Distribution
🇺🇸 United States
ARTSMedia In Vitro Culture Medium
DI: 05745000591015
·
Model: 10 mL
·
Artsmedia Denmark ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARTSMedia In Vitro Culture Medium
- Primary DI
- 05745000591015
- Version / Model
- 10 mL
- Catalog Number
- 501010
- Company Name
- Artsmedia Denmark ApS
- Labeler DUNS
- 306267547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-28
- Public Version
- 2
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 75dc3a24-3dab-4adb-8b35-8b2ec0c896c7
Device Description
ARTSMedia In Vitro Culture Medium is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.
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
- 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 | 05745000591015 | GS1 |