Morph AccessPro Steerable Introducer MAP645

GUDID 00866749000240

BIOCARDIA, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00866749000240
• NIH Device Record Key: 1ae5bee7-ce86-4424-aa89-1d8fa3902865
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Morph AccessPro Steerable Introducer
• Version Model Number: MAP645
• Catalog Number: MAP645
• Company DUNS: 122370146
• Company Name: BIOCARDIA, 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: false
• 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: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866749000240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090999

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-10-10

On-Brand Devices [Morph AccessPro Steerable Introducer]

• 00866749000257: MAP690
• 00866749000240: MAP645