MEDRAD® Avanta Single Patient Disposable Set - Angio AVA 500 SPAT ANGIO

GUDID 10616258007226

"Avanta Single-Patient Disposable Set (SET,PKG,SING-PAT,AVA500SPAT ANGIO,MC,JA) (84197068)"

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 10616258007226
• NIH Device Record Key: 670825b9-9eda-4840-b1e5-cfa8c9f14351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Single Patient Disposable Set - Angio
• Version Model Number: AVA 500 SPAT ANGIO
• Catalog Number: AVA 500 SPAT ANGIO
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258007229 [Primary]
GS1	10616258007226 [Package]; Contains: 00616258007229; 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 Single Patient Disposable Set - Angio]

• 10616258007721: Avanta Single-Patient Disposable Set (SET,PKG,SINGLE-PAT,AVA500SPATANGIO,MC,C) (60729490)
• 10616258007530: Avanta Single-Patient Disposable Set (SET,PKG,SGLE-PAT,AVA500SPAT ANGIO,MC,LA) (60729199)
• 10616258007226: "Avanta Single-Patient Disposable Set (SET,PKG,SING-PAT,AVA500SPAT ANGIO,MC,JA) (84197068)"
• 10616258005314: Avanta Single-Patient Disposable Set (ANGIO-AVANTA,SET,SNGL-PATIENT,AVA500SPAT,MC) (60729482)
• 40616258010203: Avanta Single-Patient Disposable Set (SET,PKG,SING-PAT,AVA500SPAT ANGIO,MC,JA2) (85239074)
• 40616258021452: ASSY,TBG,SNGL,ANGIO,65”,MC,WLD (86566745)
• 00616258024042: ASSY,TBG,SNGL,ANGIO,65",MC,CORE (87629066)