MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable AVA 500 SPAT L

GUDID 40616258010197

Avanta Single-Patient Disposable Set (SET,PKG,SPDS,AVA500SPATL,US FBPIV,MC,JA2) (85239082)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 40616258010197
• NIH Device Record Key: 6e87636b-34e6-4ac5-8562-9d7519120942
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable
• 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	00616258010199 [Primary]
GS1	40616258010197 [Package]; Contains: 00616258010199; 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: 2019-05-28
• Device Publish Date: 2019-05-20

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

• 10616258007738: Avanta Single-Patient Disposable Set (SET,PKG,SPDS,AVA500SPAT L,US FBPIV,MC,C) (60729512)
• 10616258007486: Avanta Single-Patient Disposable Set (SET,PKG,SPDS,AVA500SPAT L,US FBPIV,MC,LA) (60728958)
• 10616258007219: "Avanta Single-Patient Disposable Set (SET,PKG,SPDS,AVA500SPAT L,US FBPIV,MC,JA) (84197017)"
• 10616258005321: Avanta Single-Patient Disposable Set (ANGIO-AVAN,SET,SPDS,AVA500SPAT L,US FBPIV, MC) (60729504)
• 40616258010197: Avanta Single-Patient Disposable Set (SET,PKG,SPDS,AVA500SPATL,US FBPIV,MC,JA2) (85239082)