Transfer Set 017349

GUDID 37630039300358

Bracco Injeneering SA

Intravenous administration set

• Primary Device ID: 37630039300358
• NIH Device Record Key: c12e8f24-66e5-4f40-95d9-57ab2e399f7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transfer Set
• Version Model Number: 017349
• Catalog Number: 017349
• 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: true
• 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

Customer Support Contacts

• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com

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
• 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
• 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	17630039300354 [Primary]
GS1	27630039300351 [Package]; Contains: 17630039300354; Package: Box [50 Units]; In Commercial Distribution
GS1	37630039300358 [Package]; Contains: 27630039300351; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133147

FDA Product Code

• FPK: Tubing, Fluid Delivery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-20

Devices Manufactured by Bracco Injeneering SA

• 37630039302048 - Remote Control: 2024-06-06 EmpowerCTA+ Injector System, Remote Control
• 17630039301962 - Injector Head: 2024-05-06
• 17630039302037 - Injector Head: 2024-05-06
• 17630039301627 - FastLoad™ MR Syringe Pack: 2024-04-16
• 37630039301980 - IV Pole: 2024-03-11
• 37630039301997 - Floor Stand: 2024-03-11
• 47630039301949 - EmpowerCTA+ Injector System: 2024-02-13 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 47630039302014 - EmpowerCTA+ Injector System: 2023-10-25 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector