G-Vitri™ Vitrification media

Basic Information

• Brand Name: G-Vitri™ Vitrification media
• Primary DI: 06976438300019
• Version / Model: BEV1.5
• Company Name: Gimbo Medical Technology Shenzhen Co., Ltd.
• Labeler DUNS: 722458269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-16
• Public Version: 1
• Public Version Date: 2024-04-24
• Public Version Status: New
• Public Device Record Key: 220e211f-379e-42c2-b1ce-dc743e69e42d

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	06976438300019	GS1

Premarket Submissions

Submission Number	Supplement Number
K232942	000

Storage Conditions

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