VersaPAP™ Positive Airway Pressure Device

Basic Information

• Brand Name: VersaPAP™ Positive Airway Pressure Device
• Primary DI: 00762860215016
• Version / Model: 121501
• Company Name: Trudell Medical International
• Labeler DUNS: 203298203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-19
• Public Version: 1
• Public Version Date: 2020-02-27
• Public Version Status: New
• Public Device Record Key: 3c341a24-2a09-43a9-ac90-9d2ca5be9bc4

Device Description

VersaPAP™ Positive Airway Pressure Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	868.5690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61655	In-line CPAP set, non-nebulizing	A portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00762860215016	GS1
Package	10762860215013	GS1		10	In Commercial Distribution
Package	20762860215010	GS1		100	In Commercial Distribution
Previous	62860121501028	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173918	000