MC 300 Nebulizer with Mouthpiece

GUDID 00762860055506

MC 300 Nebulizer with Mouthpiece

Trudell Medical International

Nebulizing system delivery set, reusable

• Primary Device ID: 00762860055506
• NIH Device Record Key: c85b3f8d-0f7b-4556-b1e9-25f6173b44a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC 300 Nebulizer with Mouthpiece
• Version Model Number: 105550
• 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	00762860055506 [Primary]
GS1	10762860055503 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	62860105550028 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173367

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: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [MC 300 Nebulizer with Mouthpiece]

• 62860105550028: MC 300 Nebulizer with Mouthpiece
• 00762860055506: MC 300 Nebulizer with Mouthpiece