Injector head 017377

GUDID 37630039300396

Bracco Injeneering SA

MRI contrast medium injection system, line-powered, mobile

• Primary Device ID: 37630039300396
• NIH Device Record Key: 91e707b7-90cf-4902-aa53-a25a58cb7fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injector head
• Version Model Number: 017377
• Catalog Number: 017377
• 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: false
• Serial Number: true
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• 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	17630039300392 [Primary]
GS1	37630039300396 [Package]; Contains: 17630039300392; Package: Box [1 Units]; In Commercial Distribution

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 [Injector head ]

• 37630039300396: 017377
• 37630039301041: 102410
• 37630039300891: 102410
• 17630039302037: 102410
• 17630039301962: 102410