Vapotherm

Basic Information

• Brand Name: Vapotherm
• Primary DI: 00841737103103
• Version / Model: OAM-UKIT-DE
• Company Name: VAPOTHERM, INC.
• Labeler DUNS: 040429050
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-15
• Public Version: 1
• Public Version Date: 2019-10-23
• Public Version Status: New
• Public Device Record Key: fd5a9004-5c96-4f24-b4d3-0e03dba46ad2

Device Description

Precision Flow Oxygen Assist Module, Germany UKIT

Device Characteristics

• Single Use: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	868.5454	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63057	Respiratory oxygen therapy physiologic monitor/gas regulator	An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements. It is a computerized unit designed to interface between the O2 source and the patient and includes monitoring functionality, a graphic display, alarm(s), electronic gas valve, and integrated software.	No	Active
64303	Respiratory oxygen therapy pulse oximeter-regulator interface	An electrically-powered device designed to interface between a pulse oximeter probe and an electronic medical gas regulating unit during oxygen (O2) therapy, to continuously monitor haemoglobin oxygen saturation (SpO2), calculate the appropriate volume of O2 needed to be delivered to the patient based on SpO2 values, and transmit an electronic signal to the electronic O2 regulating unit. It includes a display, alarm(s), and integrated software; it does not come into direct contact with medical gases (i.e., does not include a gas regulator or tubing).	No	Active
13538	Respiratory oxygen sensor	A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.	No	Active
45804	Electrical mains power cable	An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841737103103	GS1