DISTAFLEX 111304

GUDID 00616258005096

DISTA FLEX, FG PKG

Bayer Healthcare LLC

Thrombectomy suction catheter

• Primary Device ID: 00616258005096
• NIH Device Record Key: 95882333-9aaf-4d7d-8ef9-7fdf667fdd9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTAFLEX
• Version Model Number: 111304-001
• Catalog Number: 111304
• Company DUNS: 079415074
• Company Name: Bayer Healthcare LLC
• 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: 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
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com
• Phone: 763-780-4555
• Email: michael.burnside@bayer.com

Device Dimensions

• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258005096 [Primary]

FDA Product Code

• MCX: Catheter, Coronary, Atherectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-10-07

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