Easi-Vue embolic microspheres System EVR100

GUDID 10850042341053

ABK Biomedical Incorporated

Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable Embolization particle, non-bioabsorbable

• Primary Device ID: 10850042341053
• NIH Device Record Key: cf035a0d-ed87-408a-b23b-4e24d89e0da3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easi-Vue embolic microspheres System
• Version Model Number: Refill Syringe 100 micron
• Catalog Number: EVR100
• Company DUNS: 203463617
• Company Name: ABK Biomedical Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042341056 [Primary]
GS1	10850042341053 [Package]; Contains: 00850042341056; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220567

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2022-11-01
• Device Publish Date: 2022-10-24

On-Brand Devices [Easi-Vue embolic microspheres System]

• 10850042341060: Refill Syringe 150 micron
• 10850042341053: Refill Syringe 100 micron
• 10850042341046: Refill Syringe 50 micron
• 00850042341032: Administration Kit 150 micron
• 00850042341025: Administration Kit 100 micron
• 00850042341018: Administration Kit 50 micron
• 10850042341107: EVD150
• 10850042341091: EVD100
• 00850042341087: EVD50