ANGIOJET 105650

GUDID 00616258003900

ULTRA SYSTEM CONSOLE, FG

Bayer Healthcare LLC

General-purpose suction system, line-powered

• Primary Device ID: 00616258003900
• NIH Device Record Key: f19c8228-266a-4192-8414-fd375ee75d77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANGIOJET
• Version Model Number: 105650-001
• Catalog Number: 105650
• Company DUNS: 079415074
• Company Name: Bayer Healthcare LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258003900 [Primary]

FDA Product Code

• MCX: Catheter, Coronary, Atherectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-10-09

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