FloWire Doppler Guide Wire XT 300cm 014 JTIP

GUDID 00184360000204

VOLCANO CORPORATION

Blood flowmeter catheter, Doppler

• Primary Device ID: 00184360000204
• NIH Device Record Key: 347e7154-72b5-48ea-8862-a1d44ee4cf5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloWire Doppler Guide Wire XT 300cm 014 JTIP
• Version Model Number: 1413J
• Company DUNS: 135179237
• Company Name: VOLCANO CORPORATION
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00184360000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972762

FDA Product Code

• DQX: Wire, Guide, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

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