• Aurika Savickaite

BUY a Helmet! Where to get a Helmet?

Updated: Oct 8

USA Distributor for Italian StarMed CaStar R Hood, New York (Shipping now)

FDA EUA Approved for non-invasive ventilation and CPAP use in a hospital environment




As of August 14th, 2020. StarMed Helmet is approved by the FDA to use for non-invasive ventilation and CPAP in the hospital environment. The treatment may only be performed under careful monitoring by expert operators. Suitable for treatment of respiratory insufficiency in hypoxemic/hypercapnic adult patients.

You can send your inquiry directly to the manufacturer here

Hands-On Review Video - NIV StarMed CaStar R Hood from Intersurgical Ltd

USA Manufacturer Rhode Island (Shipping now)

FDA EUA Approved for non-invasive ventilation and CPAP use in a hospital environment

Maternova Inc. - "Subsalve" Helmet Distributer in Latin American countries


The Health Bank - "Subsalve" Helmet Distributor in the Middle East, Nigeria, and South Africa

"Effective August 4, 2020. The device has been added to Appendix B of the FDA’s EUA for ventilator accessories, and is specifically indicated for the treatment of ARDS resulting from Covid-19. At the present time, the Subsalve Oxygen Treatment Hood is the only such device with this specific indication as authorized by the FDA" Michael Lombardi.

4/9/2020 Lombardi Undersea LLC in partnership with Subsalve USA, both of Rhode Island USA is producing and shipping oxygen treatment hoods. Orders can be placed online or by submitting a PO to Michael Lombardi at michael@lombardiundersea.com.


Read More

The nHale + Hood configuration

nHale™ provides bi-level positive air pressure and CPAP to support respiratory therapy for spontaneously breathing adults.

An instructional video for nHale and Subsalve hood connection:


Hood+CPAP Technique Informational Sheet
.pdf
Download PDF • 628KB

Hood+CPAP Configuration Guide for nHale
.pdf
Download PDF • 306KB


PEEP-Alert is an accessory that provides continuous monitoring of positive pressure therapy and has Audible/visual alarms.

Authorized by the FDA for Emergency Use (EUA) and by Health Canada under COVID-19 Interim Order


PEEP-Alert_InfoSheet April 2021
.pdf
Download PDF • 900KB


USA Manufacturer Texas

FDA Approved for use in Hyperbaric Facilities

Sea-Long Medical Systems Inc Waxahachie, TX 75167

USA Manufacturer California

FDA Approved for use in Hyperbaric Facilities

Amron International, Inc Vista, California

Mike Malone, Vice President Sales, Phone: 760.208.6500

NIV/CPAP/BIPAP Hood's Description and Features

Coming soon to US - Italian DIMAR CPAP and PSV Helmets

Filed for FDA EUA Approval

USA Manufacturer New York

Filed for FDA EUA Approval


You can order this helmet directly from the manufacturer here.

Hands-On Review Video - VYATIL Oxygen Tent from The LMD Power of Light


New Zealand


FDA Registration on Suzy MCP-Tent-001, Available in the USA

SouthMed Dunedin, New Zealand. Sales contact: enquiries@southmed.co.nz


Suzy MCP-Tent-001 Oxygen Tent
Suzy MCP-Tent-001 Oxygen Tent

Suzy MCP-001 Respiratory Hood available in New Zealand


Suzy MCP-001 Respiratory Hood

Italy


DIMAR s.r.l. Medolla, Italy


Harol, Milan, Italy Video instructions.

Intersurgical Ltd. Mirandola, Italy

UK


Armstrong Medical. Coleraine, Northern Ireland.

CPAP Helmets / Hoods deliver CPAP safely

while providing great patient comfort and aerosol-protection for staff:

The FD140i provides a dedicated CPAP Helmet Mode

with enhanced safety features:


Intersurgical Ltd. Berkshire, UK

Lithuania


Italian manufacturer's representative: UAB Intersurgical Arnionių g. 60, LT-18170 Pabradė, Lietuva


India


Manufacturer Phoenix Medical Systems, India (Shipping Now)

Hands-On Review Video and more info about Haven Hood

Canada

Alberta COVID CPAP Hood - Scott Loree "I have been working for 4 weeks with Tom Vermeeren, from Gemma Plastics in Edmonton, Alberta, to develop a locally manufactured version of this helmet system. We have received Health Canada approval 4/24/2020, and are ready to move into manufacturing. "


Poland

DYI initiative by Marek Macner - Helmochron is in Polish language new word - helm = helmet and ochrona = protection.

USA Manufacturer Michigan (Working prototypes are being tested in hospitals 4/14)

Filed for FDA EUA Approval

A manufacturer located in Zeeland, MI. They have been working with multiple hospitals testing helmets. You can order a helmet here. Contact: Nick Flesher phone: 616-283-3342




DIY & Additional Resources

List of companies offering to help make more helmets.

(Updated daily) Our goal is to help make more helmets faster and educate medical professionals! We are adding information about companies offering to help to this public spreadsheet so everybody can connect directly (started on 4/1). Link: https://hi.switchy.io/HELP-Make-Helmets


Facebook Group "NIV Helmet Manufacturing Project to Combat COVID-19"

The objective of this group is to design and create a working NIV Helmet and to release all associated 3D printing files, bill of materials, and building instructions online so that anyone around the world may build one in an emergency situation in order to Combat COVID-19.