CardioGen Patient Administration Set

GUDID 30815112021352

Patient Administration Set for use with CardioGen-82 Infusion System

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 Radiographic procedure tubing

• Primary Device ID: 30815112021352
• NIH Device Record Key: 3f6de6d7-3992-4404-8faa-e953a42d154a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioGen Patient Administration Set
• Version Model Number: 001506
• 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: true
• Single Use: true
• 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
• 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 excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815112021358 [Primary]
GS1	30815112021352 [Package]; Contains: 10815112021358; Package: [25 Units]; In Commercial Distribution
GS1	50815112021356 [Package]; Package: [5 Units]; In Commercial Distribution

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: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [CardioGen Patient Administration Set]

• 10815112020023: Patient Administration Set for use with CardioGen-82 Infusion System
• 30815112021352: Patient Administration Set for use with CardioGen-82 Infusion System