Floor Stand 016204

GUDID 37630039300402

Bracco Injeneering SA

MRI contrast medium injection system, line-powered, mobile MRI contrast medium injection system, line-powered, mobile

• Primary Device ID: 37630039300402
• NIH Device Record Key: b9bc6795-9aa7-468b-9c4d-beb70d8b0e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Floor Stand
• Version Model Number: 016204
• Catalog Number: 016204
• Company DUNS: 482489007
• Company Name: Bracco Injeneering SA
• 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: true
• Expiration Date: false
• 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: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	37630039300402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062449

FDA Product Code

• IZQ: Injector, Contrast Medium, Automatic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Floor Stand]

• 37630039300693: 017410
• 37630039300402: 016204
• 37630039300143: 640076
• 37630039301218: 640076
• 37630039301997: 017410