MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible AVA 500 SPAT L

GUDID 40616258021483

ASSY,TBG,SNGL,ANGIO,65”,PIV,MC,WLD (86566656)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 40616258021483
• NIH Device Record Key: 5ec311c0-7c2d-4635-9592-89cfe44998c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible
• Version Model Number: AVA 500 SPAT L
• Catalog Number: AVA 500 SPAT L
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021485 [Primary]
GS1	40616258021483 [Package]; Contains: 00616258021485; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050456

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible]

• 40616258021483: ASSY,TBG,SNGL,ANGIO,65”,PIV,MC,WLD (86566656)
• 40616258024088: ASSY,TBG,SNGL,ANGIO,65",PIV,MC,CORE (87629104)