Vapotherm

Basic Information

• Brand Name: Vapotherm
• Primary DI: 00841737103608
• Version / Model: FELIX-1
• Company Name: VAPOTHERM, INC.
• Labeler DUNS: 040429050
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-27
• Public Version: 2
• Public Version Date: 2021-05-04
• Public Version Status: Update
• Public Device Record Key: 33d0fd54-10f5-4d09-93f1-a79d43730832

Device Description

FELIX-1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
65074	Negative-pressure face tent	A mask-like enclosure, with tubing for connection to a hospital suction system, designed to rest against the chin of a patient while remaining away from the face, and intended to create a negative pressure area near the patient’s nose and mouth to suction exhaled air and reduce the dispersal of potentially infectious particulates into the local environment. It is typically used while treating patients with airborne or droplet-transmitted infectious diseases (e.g., COVID-19). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841737103608	GS1