AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

GUDID 10762860055411

AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

Trudell Medical International

Nebulizing system delivery set, reusable

• Primary Device ID: 10762860055411
• NIH Device Record Key: 7e5d16c9-240c-4f63-a59c-d9f74499f631
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing
• Version Model Number: 105541
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00762860055414 [Primary]
GS1	10762860055411 [Package]; Contains: 00762860055414; Package: [50 Units]; In Commercial Distribution
GS1	62860105541026 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053605

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-27
• Device Publish Date: 2020-02-19

On-Brand Devices [AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing]

• 62860105541026: AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing
• 10762860055411: AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing