FDA UDI
In Commercial Distribution
🇺🇸 United States
DEWIN
DI: 06972962312436
·
Model: 9340
·
DonneVie Medical Technology(Shanghai)Co.Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DEWIN
- Primary DI
- 06972962312436
- Version / Model
- 9340
- Company Name
- DonneVie Medical Technology(Shanghai)Co.Ltd
- Labeler DUNS
- 554479334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-08
- Public Version
- 1
- Public Version Date
- 2022-07-18
- Public Version Status
- New
- Public Device Record Key
- bc83c264-fde8-4a6e-ad8f-e98946229dc0
Device Description
Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures.
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
- Yes
- 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 | 06972962312436 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212426 | 000 |