Day Set III HP

GUDID 37630039301577

Bracco Injeneering SA

Contrast medium injection system syringe

• Primary Device ID: 37630039301577
• NIH Device Record Key: e4d1de1c-0249-409d-99c3-cfb78c6a52b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Day Set III HP
• Version Model Number: 640460
• 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: 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
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630039300026 [Previous]
GS1	17630039301573 [Primary]
GS1	37630039301577 [Package]; Contains: 17630039301573; Package: box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151048

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: 2020-05-14
• Device Publish Date: 2020-05-06

On-Brand Devices [Day Set III HP]

• 37630039301577: 640460
• 37630039301881: Day Set DEHT to be used with CT Exprès injectors