Vapotherm

Basic Information

• Brand Name: Vapotherm
• Primary DI: 00841737100140
• Version / Model: PF-UNIT
• Company Name: VAPOTHERM, INC.
• Labeler DUNS: 040429050
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-05
• Public Version: 6
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 5ea20c65-95ae-46d5-bf34-ff167a7a3264

Device Description

Precision Flow

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57828	Professional high-flow respiratory unit, humidifying	An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen to a patient in a peri-anaesthesia environment or experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered as part of noninvasive ventilation (NIV) to the patient's airway via the nose/mouth or a tracheostoma. It consists of a gas flow generator, a heating element, and humidification chamber. It is intended to be used by a healthcare provider on a spontaneously breathing patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841737100140	GS1

Premarket Submissions

Submission Number	Supplement Number
K072845	000