OMBRA 120V Table Top Compressor System 10551094006

GUDID 62860105510022

OMBRA Table Top Compressor System (120V)

Trudell Medical International

Medical device air compressor Medical device air compressor

• Primary Device ID: 62860105510022
• NIH Device Record Key: 837b4980-861d-4db3-b0bf-bb3016f3c266
• Commercial Distribution Discontinuation: 2020-04-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OMBRA 120V Table Top Compressor System
• Version Model Number: 105510
• Catalog Number: 10551094006
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• Device Count: 6
• 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: true
• 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: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	62860105510015 [Unit of Use]
GS1	62860105510022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131881

FDA Product Code

• BTI: Compressor, Air, Portable

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

Devices Manufactured by Trudell Medical International

• 10762860001135 - RESPICHAMBER* VHC with Mouthpiece: 2024-03-19 RESPICHAMBER™ VHC with Mouthpiece
• 10762860055022 - REUSABLE COMFORTSEAL® Silicone Mask Assembly: 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Medium For use with the family of AeroEclipse® nebulizers
• 10762860055039 - REUSABLE COMFORTSEAL® Silicone Mask Assembly: 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® nebulizers
• 10762860055046 - REUSABLE COMFORTSEAL® Silicone Mask Assembly: 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Large For use with the family of AeroEclipse® nebulizers
• 00762860000827 - AEROCHAMBER* MV Holding Chamber: 2023-12-11 AEROCHAMBER* MV Holding Chamber
• 10762860055572 - MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing: 2021-06-29 MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing
• 10762860055534 - AeroEclipse® ONE Breath Actuated Nebulizer Disposable: 2020-08-11 AeroEclipse® ONE Breath Actuated Nebulizer Disposable
• 10762860105024 - AEROBIKA OPEP Manometer: 2020-04-30 AEROBIKA OPEP Manometer