MEDRAD® Avanta Multi-Patient Disposable Syringe AVA 500 MPAT (Part 1 of 2)

GUDID 10616258005550

Avanta Multi-Patient Disposable Set (SET, PKG, MEDRAD AVANTA, SYRINGE, RAD S) (60729407)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 10616258005550
• NIH Device Record Key: b66f95ca-ee9d-48d0-ace2-d68d1d3469a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Multi-Patient Disposable Syringe
• Version Model Number: AVA 500 MPAT (Part 1 of 2)
• Catalog Number: AVA 500 MPAT (Part 1 of 2)
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258005553 [Primary]
GS1	10616258005550 [Package]; Contains: 00616258005553; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [MEDRAD® Avanta Multi-Patient Disposable Syringe]

• 10616258007851: Avanta Multi-Patient Disposable Set (SET,PKG,MEDRAD AVANTA,SYRINGE,RAD,MC,CH) (60729423)
• 10616258007417: Avanta Multi-Patient Disposable Set (SET,PKG,MEDRAD AVANTA,SYRINGE,RAD,MC,LA) (60729415)
• 10616258005550: Avanta Multi-Patient Disposable Set (SET, PKG, MEDRAD AVANTA, SYRINGE, RAD S) (60729407)
• 40616258021735: AVANTA,KIT,SYR,ANGIO,150ML,MC,WLD (86617455)