Fast Warm-NX with Gentamicin

Basic Information

• Brand Name: Fast Warm-NX with Gentamicin
• Primary DI: 00810195241603
• Version / Model: 6x2ML
• Catalog Number: 90196
• Company Name: IRVINE SCIENTIFIC, LLC
• Labeler DUNS: 121584789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-09
• Public Version: 1
• Public Version Date: 2026-01-19
• Public Version Status: New
• Public Device Record Key: 8a54780e-38b0-496a-baa4-2c0e25462244

Device Description

Fast Warm-NX is a dual solution (HEPES and MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) Dextran Serum Supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50mg/mL therapeutic grade Human Serum Albumin (HSA) and 20mg/mL Dextran. DSS is used at 20% (v/v) in Fast Warm-NX for a final concentration of 10mg/mL HSA and 4 mg/mL Dextran. Fast Warm-NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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	00810195241603	GS1

Premarket Submissions

Submission Number	Supplement Number
K250445	000

Storage Conditions

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