Accessory Package

GUDID 50815112020038

Accessory Package for use with CardioGen-82 Infusion System, Model 510

BRACCO DIAGNOSTICS INC

Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing

• Primary Device ID: 50815112020038
• NIH Device Record Key: 3abf7f5c-bad9-46c5-81ca-a98aca90c0a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accessory Package
• Version Model Number: 001510
• Company DUNS: 849234661
• Company Name: BRACCO DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx
• Phone: 800-447-6883
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature . Avoid excess heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	30815112020034 [Primary]
GS1	50815112020038 [Package]; Contains: 30815112020034; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883609

FDA Product Code

• FRN: Pump, Infusion

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: 2023-03-30
• Device Publish Date: 2023-03-22

On-Brand Devices [Accessory Package]

• 50815112020618: Accessory Package for use with CardioGen-82 Infusion System
• 50815112020038: Accessory Package for use with CardioGen-82 Infusion System, Model 510
• 50815112021332: Accessory Package for use with CardioGen-82 Infusion System