MicroMewiTM

GUDID 00847536008052

INF CATH 41066-01 MICROMEWI V03

Micro Therapeutics, Inc.

Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: 00847536008052
• NIH Device Record Key: ad404c48-1654-4de3-b3f6-bff096981e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroMewiTM
• Version Model Number: 41066-01
• 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536008052 [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: true
• Device Is Sterile: true

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

[00847536008052]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-04-01

On-Brand Devices [MicroMewiTM]

• 00847536008076: INF CATH 41067-01 MICROMEWI V03
• 00847536008052: INF CATH 41066-01 MICROMEWI V03
• 00847536008038: INF CATH 41064-01 MICROMEWI V03
• 00847536008014: INF CATH 41063-01 MICROMEWI V03