EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN 10551494010

GUDID 62860105514020

EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN

Trudell Medical International

Nebulizing system, non-heated

• Primary Device ID: 62860105514020
• NIH Device Record Key: 643d904b-c6b8-4a2c-86b8-dea99b54df43
• Commercial Distribution Discontinuation: 2020-04-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN
• Version Model Number: 105514
• Catalog Number: 10551494010
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• Device Count: 10
• 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	62860105514013 [Unit of Use]
GS1	62860105514020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080926

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-23
• Device Publish Date: 2016-09-30

On-Brand Devices [EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN]

• 62860105514020: EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN
• 00762860050303: EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN