FDA UDI
In Commercial Distribution
🇺🇸 United States
Oocyte Retrieval Buffer
DI: 09348265004076
·
Model: ORB-20
·
GENEA BIOMEDX PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oocyte Retrieval Buffer
- Primary DI
- 09348265004076
- Version / Model
- ORB-20
- Company Name
- GENEA BIOMEDX PTY LTD
- Labeler DUNS
- 752103403
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-25
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b4e75bd2-3367-4aed-8fb9-28870d8f1a5f
Device Description
The Gems Oocyte Retrieval Buffer is an assisted reproduction medium used for removal of oocytes from ovarian follicles. It consists of salts, energy substrates, amino acids buffering agents, stabilizers and antibiotics. This device has direct contact with the patients and oocytes. This product is a single-use device that is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10^-3. It is tested for pH, osmolality, embryotoxicity, endotoxin and sterility before lot release and has a shelf-life of 30 weeks.
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 | 09348265004076 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170498 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius