Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS 90133-SO

GUDID 00810195240316

Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 2x1mL Vials Equilibration Solution - ES (white cap) and 2x1mL Vials Vitrification Solution - VS (blue cap)

IRVINE SCIENTIFIC, LLC

IVF medium

• Primary Device ID: 00810195240316
• NIH Device Record Key: 01ce28d9-7721-4dba-a2d9-e31a0b19c681
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS
• Version Model Number: 90133-SO
• Catalog Number: 90133-SO
• 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: true
• 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	00810195240316 [Primary]

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 [Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS]

• 00810195240323: Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 9x1mL Vials Equilib
• 00810195240316: Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 2x1mL Vials Equilib