AZUR Detachment Controller 45-4001

GUDID 00840273201991

AZUR Detachment Controller

MICROVENTION INC.

Vascular implant detacher, electronic, single-use

• Primary Device ID: 00840273201991
• NIH Device Record Key: f17df65c-d8b5-4502-bc5f-17b4ea251cae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AZUR Detachment Controller
• Version Model Number: 45-4001-02
• Catalog Number: 45-4001
• Company DUNS: 003263105
• Company Name: MICROVENTION INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Storage Environment Humidity: Between 0 and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840273201991 [Primary]

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: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [AZUR Detachment Controller]

• 10810170012126: Azur
• 00840273201991: AZUR Detachment Controller