VersaPAP™ Positive Airway Pressure Device 12150194010

GUDID 62860121501028

VersaPAP™ Positive Airway Pressure Device

Trudell Medical International

In-line CPAP set, non-nebulizing In-line CPAP set, non-nebulizing

• Primary Device ID: 62860121501028
• NIH Device Record Key: 31aeff1c-5d15-4803-b743-fdf1fc7b7331
• Commercial Distribution Discontinuation: 2020-04-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VersaPAP™ Positive Airway Pressure Device
• Version Model Number: 121501
• Catalog Number: 12150194010
• 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: true
• 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	62860121501011 [Unit of Use]
GS1	62860121501028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173918

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-23
• Device Publish Date: 2018-09-10

On-Brand Devices [VersaPAP™ Positive Airway Pressure Device]

• 62860121501028: VersaPAP™ Positive Airway Pressure Device
• 62860121501035: VersaPAP™ Positive Airway Pressure Device
• 00762860215016: VersaPAP™ Positive Airway Pressure Device