VersaPAP™ Positive Airway Pressure Device

Basic Information

• Brand Name: VersaPAP™ Positive Airway Pressure Device
• Primary DI: 62860121501035
• Version / Model: 121501
• Catalog Number: 12150194100
• Company Name: Trudell Medical International
• Labeler DUNS: 203298203
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-03-27
• Public Version: 3
• Public Version Date: 2020-04-23
• Public Version Status: Update
• Public Device Record Key: 516f5ad8-5beb-4199-a46c-79cb8c340c08
• Distribution End Date: 2020-04-22

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	62860121501035	GS1
Unit of Use	62860121501011	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173918	000