FDA UDI
In Commercial Distribution
🇺🇸 United States
SSS-NX (Serum Substitute Supplement-NX)
DI: 00857515006634
·
Model: 90194 100 mL
·
FUJIFILM IRVINE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SSS-NX (Serum Substitute Supplement-NX)
- Primary DI
- 00857515006634
- Version / Model
- 90194 100 mL
- Catalog Number
- 90194
- Company Name
- FUJIFILM IRVINE SCIENTIFIC, INC.
- Labeler DUNS
- 057475246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-29
- Public Version
- 2
- Public Version Date
- 2025-06-16
- Public Version Status
- Update
- Public Device Record Key
- 9dc5cd1e-ef48-47c4-898f-6ef9ace0f616
Device Description
SSS-NX (Serum Substitute Supplement-NX) consists of human serum albumin and human serum globulins in saline solution and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for culture medium.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- 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 | 00857515006634 | GS1 |
Customer Contacts
- Phone
- 8004375706
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius