FastLoad™ MR Syringe Pack 017348

GUDID 17630039301627

Bracco Injeneering SA

Basic intravenous administration set, noninvasive

• Primary Device ID: 17630039301627
• NIH Device Record Key: 8310b110-e76a-4fa4-a63c-8933c7dfc677
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastLoad™ MR Syringe Pack
• Version Model Number: 017348
• Catalog Number: 017348
• 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: 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

• 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	17630039301627 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [FastLoad™ MR Syringe Pack ]

• 37630039300860: 017356
• 37630039300297: 017348
• 17630039301627: 017348