Multipurpose Handling Medium (MHM) with Gentamicin

Basic Information

• Brand Name: Multipurpose Handling Medium (MHM) with Gentamicin
• Primary DI: 00810195240248
• Version / Model: 90163-100ML
• Catalog Number: 90163
• Company Name: IRVINE SCIENTIFIC, LLC
• Labeler DUNS: 121584789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-02
• Public Version: 1
• Public Version Date: 2025-06-10
• Public Version Status: New
• Public Device Record Key: 3340b239-ef71-465e-8595-9c6fa9e15891

Device Description

Multipurpose Handling Medium (MHM) with Gentamicin is dual buffered solution (HEPES and MOPS) that provides a safe and secure environment to maintain viability of gametes and embryos during manipulations under ambient conditions.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: 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	00810195240248	GS1

Premarket Submissions

Submission Number	Supplement Number
K121128	000

Storage Conditions

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