Riptide™

GUDID 00847536029101

ASPIRATION PUMP MAP-1000 V01 US

Micro Therapeutics, Inc.

Surgical irrigation/aspiration system

• Primary Device ID: 00847536029101
• NIH Device Record Key: f2cc4a91-6fcd-4012-9dd1-b78625dffae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Riptide™
• Version Model Number: MAP-1000
• 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: false
• Lot Batch: false
• Serial Number: true
• 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
• 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
• 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
• 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 Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 68 KiloPascal and 105 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536029101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172448

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-15
• Device Publish Date: 2018-07-16

On-Brand Devices [Riptide™]

• 00847536029118: ASPIRATION TUBING AT-88-110 V01 US
• 00847536029101: ASPIRATION PUMP MAP-1000 V01 US
• 00847536029095: CANISTER MAC-1200 V01 US
• 00847536034839: TUBING MAT-110-110 V01
• 00763000299439: TUBING MAT-110-110 V04 NA RIPTIDE
• 00763000299422: CANISTER MAC-1200 V04 NA RIPTIDE
• 00763000299415: PUMP MAP-1000 V02 NA RIPTIDE