Morph Universal Deflectable Guide Catheter 00895

GUDID 00866749000202

BIOCARDIA, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00866749000202
• NIH Device Record Key: 9e1f7d27-e3bd-47a9-83ef-10f6a300523d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Morph Universal Deflectable Guide Catheter
• Version Model Number: 00895
• Catalog Number: 00895
• 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	00866749000202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012749

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

[00866749000202]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

[00866749000202]

Ethylene Oxide

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

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