FDA UDI
In Commercial Distribution
🇺🇸 United States
Enhance Sperm Freeze
DI: 00805360018968
·
Model: 15765
·
VITROLIFE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Enhance Sperm Freeze
- Primary DI
- 00805360018968
- Version / Model
- 15765
- Company Name
- VITROLIFE INC.
- Labeler DUNS
- 051915038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-23
- Public Version
- 3
- Public Version Date
- 2020-04-29
- Public Version Status
- Update
- Public Device Record Key
- 4c759c6c-3352-4f9c-8620-34a4fd9290db
Device Description
Enhance Sperm Freeze, 100mL
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
- 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 |
|---|---|---|---|---|
| 52734 | Red cell freezing/cryoprotectant solution IVD | A substance or reactant intended to be used for the preservation and/or cryoprotection of red blood cells during frozen storage of a clinical specimen so as to maintain their suitability for further in vitro testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00805360018968 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030117 | 000 |