Display Control Unit Sheath AVA 500 DCOV

GUDID 00616258005355

Avanta Single Use Display Control Unit Sheath (ANGIO - AVANTA, SHEATH, DCU, MC) (60729563)

BAYER MEDICAL CARE INC.

Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00616258005355
• NIH Device Record Key: 5edc2c69-2a3b-474d-a003-801f9e30c73a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Display Control Unit Sheath
• Version Model Number: AVA 500 DCOV
• Catalog Number: AVA 500 DCOV
• 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: false
• 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	00616258005355 [Primary]
GS1	10616258005352 [Package]; 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 [Display Control Unit Sheath]

• 00616258007557: Avanta Single Use Display Control Unit Sheath (SHEATH, DISPLAY CONTROL UNIT, MC, LA) (60728583)
• 10616258007189: Avanta Single Use Display Control Unit Sheath (SHEATH, DISPLAY CONTROL UNIT,MC,JA) (84194875)
• 00616258005355: Avanta Single Use Display Control Unit Sheath (ANGIO - AVANTA, SHEATH, DCU, MC) (60729563)
• 40616258010234: Avanta Single Use Display Control Unit Sheath(SHEATH, DISPLAY CONTROL UNIT,MC,JA2)(85231472)
• 40616258021551: SHEATH,DISPLAY CONTROL UNIT,MC,WLD (86566737)
• 40616258024866: SHEATH,DISPLAY CONTROL UNIT,MC,CORE (87640515)