SSS-NX (Serum Substitute Supplement-NX)

Basic Information

• Brand Name: SSS-NX (Serum Substitute Supplement-NX)
• Primary DI: 00857515006641
• Version / Model: 90194 12x10 mL
• Catalog Number: 90194
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Labeler DUNS: 057475246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• 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: e0f94bad-0086-4bb6-8386-9002c3696b5d

Device Description

SSS-NX Serum Substitute Supplement-N 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	00857515006641	GS1
Unit of Use	01085751500664	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius