Modified HTF Medium with Gentamicin 90126

GUDID 00810195240439

Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.

IRVINE SCIENTIFIC, LLC

IVF medium

• Primary Device ID: 00810195240439
• NIH Device Record Key: 4e62a6a6-1072-49a5-8fc5-31ab5d609d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modified HTF Medium with Gentamicin
• Version Model Number: 90126-500ML
• Catalog Number: 90126
• Company DUNS: 121584789
• Company Name: IRVINE SCIENTIFIC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810195240439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983586

FDA Product Code

• MQL: Media, Reproductive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-10
• Device Publish Date: 2025-06-02

On-Brand Devices [Modified HTF Medium with Gentamicin]

• 00810195240439: Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handlin
• 00810195240422: Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handlin