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

GUDID 10616258005307

Avanta Multi-Patient Disposable Set (ANGIO-AVANTA,Packaged, MPDS w/HPFCV,MC) (60729431)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 10616258005307
• NIH Device Record Key: 7b4b3466-8200-4c27-baf0-fe3aec0565aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Multi-Patient Disposable Set
• Version Model Number: AVA 500 MPAT (Part 2 of 2)
• Catalog Number: AVA 500 MPAT (Part 2 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	00616258005300 [Primary]
GS1	10616258005307 [Package]; Contains: 00616258005300; 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 Set]

• 10616258007714: Avanta Multi-Patient Disposable Set (Assy,Packaged,Avanta,MPDS w/HPFCV,MC,CH) (60729458)
• 10616258007479: Avanta Multi-Patient Disposable Set (Assy,Packaged,Avanta,MPDS w/HPFCV,MC, LA) (60728907)
• 10616258007202: Avanta Multi-Patient Disposable Set (ASSY,PKG,AVANTA,MPDS w/HPFCV,MC,JA) (84194867)
• 10616258005307: Avanta Multi-Patient Disposable Set (ANGIO-AVANTA,Packaged, MPDS w/HPFCV,MC) (60729431)
• 40616258010180: Avanta Multi-Patient Disposable Set(ASSY,PKG,AVANTA,MPDS w/HPFCV,MC,JA2) (85236156)
• 40616258021469: ASSY,TBG,MULTI,ANGIO,MC,WLD (86566648)
• 40616258024361: AVANTA,KIT,SYR,ANGIO,150ML,MC,CORE (87622525)
• 40616258024002: ASSY,TBG,MULTI,ANGIO,MC,CORE (87629007)