AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing 10554194050

GUDID 62860105541026

AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

Trudell Medical International

Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 62860105541026
• NIH Device Record Key: b6cb4922-88ba-4406-8925-5f9a2c74e48a
• Commercial Distribution Discontinuation: 2020-04-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing
• Version Model Number: 105541
• Catalog Number: 10554194050
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• Device Count: 50
• 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
• 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	62860105541019 [Unit of Use]
GS1	62860105541026 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-23
• Device Publish Date: 2016-09-24

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