MicroMewi 41067-01

GUDID 00836462000377

Multiple Sidehole Infusion Catheter

Micro Therapeutics, Inc.

Peripheral vascular infusion catheter

• Primary Device ID: 00836462000377
• NIH Device Record Key: 68af8cb6-8ea8-413c-8af5-cdaa03b0b928
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroMewi
• Version Model Number: 41067-01
• Catalog Number: 41067-01
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Catheter Gauge: 2.9 French
• Length: 180 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 2.9 French
• Length: 180 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 2.9 French
• Length: 180 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 2.9 French
• Length: 180 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 2.9 French
• Length: 180 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 2.9 French
• Length: 180 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 2.9 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462000377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940634

FDA Product Code

• FOZ: Catheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2015-10-09

On-Brand Devices [MicroMewi]

• 00836462000377: Multiple Sidehole Infusion Catheter
• 00836462000360: Multiple Sidehole Infusion Catheter
• 00836462000346: Multiple Sidehole Infusion Catheter
• 00836462000339: Multiple Sidehole Infusion Catheter