Echelon

GUDID 00836462006140

103-5095 SYRINGE ADAPTER 20-CRTN

Micro Therapeutics, Inc.

General-purpose catheter connector, sterile

• Primary Device ID: 00836462006140
• NIH Device Record Key: 20768623-3720-4332-ba49-abcf5feac56f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echelon
• Version Model Number: 103-5095
• 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(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
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462006140 [Package]; Contains: 00847536003446; Package: PK [20 Units]; In Commercial Distribution
GS1	00847536003446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090870

FDA Product Code

• KRA: Catheter, continuous flush

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: 2019-08-22
• Device Publish Date: 2015-10-23

On-Brand Devices [Echelon]

• 00836462006140: 103-5095 SYRINGE ADAPTER 20-CRTN
• 00836462002371: 14 Micro Catheter;90 Degree Tip Shape
• 00836462002364: 14 Micro Catheter;45 Degree Tip Shape
• 00836462002357: 10 Micro Catheter;90 Degree Tip Shape
• 00836462002340: 10 Micro Catheter;45 Degree Tip Shape
• 00836462002258: 14 Micro Catheter
• 00836462002241: 10 Micro Catheter