Accessory Package

GUDID 50815112020038

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

BRACCO DIAGNOSTICS INC

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