FDA UDI
In Commercial Distribution
🇺🇸 United States
SPERMCARE Upper Layer - Gradient System
DI: 00859268006183
·
Model: 2221-50
·
INVITROCARE, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SPERMCARE Upper Layer - Gradient System
- Primary DI
- 00859268006183
- Version / Model
- 2221-50
- Catalog Number
- 2221-50
- Company Name
- INVITROCARE, INCORPORATED
- Labeler DUNS
- 190094230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9df8b36e-70a5-4d7c-ac5d-32d3cbea6dc1
Device Description
SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Upper Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00859268006183 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053494 | 000 |