Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS 90137-DSOC

GUDID 00810195240347

Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 8x2mL Vials Thawing Solution-TS (yellow cap), 5x2mL Vials Dilution Solution-DS (orange cap) and 5x2mL Vials Washing Solution-WS (red cap).

IRVINE SCIENTIFIC, LLC

IVF medium

• Primary Device ID: 00810195240347
• NIH Device Record Key: 9afb0b23-5075-406d-8b71-f28f37ef8296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS
• Version Model Number: 90137-DSOC
• Catalog Number: 90137-DSOC
• 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	00810195240347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160006

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 Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS]

• 00810195240347: Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 8x2mL Vials Thawing Sol
• 00810195240330: Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 4x2mL Vials Thawing Sol