FDA UDI
In Commercial Distribution
🇺🇸 United States
Fortuna
DI: 00888937013931
·
Model: FORTUNA 1800 IVF
·
RESEARCH INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fortuna
- Primary DI
- 00888937013931
- Version / Model
- FORTUNA 1800 IVF
- Catalog Number
- WF1800LE
- Company Name
- RESEARCH INSTRUMENTS LIMITED
- Labeler DUNS
- 536139413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-19
- Public Version
- 1
- Public Version Date
- 2024-09-27
- Public Version Status
- New
- Public Device Record Key
- e1be53eb-a599-45f5-aded-130647e8772f
Device Description
In Vitro Fertilization IVF Workstation
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUB | Accessory, Assisted Reproduction, Exempt | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 20652 | Class-I biological safety cabinet | A furniture-like device designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens). It typically utilizes laminar airflow (LAF), a high-efficiency particulate air (HEPA) filter and/or carbon filter, and may have a hydrogen peroxide (H2O2) connection as some of the protective mechanisms. It is used for handling cell cultures and human pathogens (e.g., bacteria, viruses, parasites) and other biohazardous materials, extremely toxic agents (e.g., chemotherapy drugs), and also for tissue culture and tumour virus work. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937013931 | GS1 |