Vitrification Solution Set

Basic Information

• Brand Name: Vitrification Solution Set
• Primary DI: 00860012751648
• Version / Model: 210
• Catalog Number: 210
• Company Name: EXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLC
• Labeler DUNS: 103842991
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-03
• Public Version: 1
• Public Version Date: 2026-04-13
• Public Version Status: New
• Public Device Record Key: 311ae8d2-bfed-43e8-9e7d-efd71a259e1d

Device Description

Vitrification Solution Set, Reproductive Media and Supplements intended for use in the vitrification of oocytes, pronuclear zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos

Device Characteristics

• Single Use: Yes
• 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: No
• 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
42850	IVF medium kit	A collection of solutions used to provide 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 solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012751648	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 VIALS OF 1.8ML ES
Device Size Text, specify			4 VIALS OF 1.8ML VS

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 25 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius