Newtowne Tent Chamber

Basic Information

• Brand Name: Newtowne Tent Chamber
• Primary DI: 00852834007003
• Version / Model: V1.0
• Company Name: TYPHOON WATER WARES LTD
• Labeler DUNS: 361527229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-28
• Public Version: 1
• Public Version Date: 2024-06-05
• Public Version Status: New
• Public Device Record Key: 6b86b9fd-10b3-420d-ba3f-8c643fa4e041

Device Description

Tent shaped hyperbaric chamber for home with a single front zipper. Patient is seated in a chair while under pressure.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
CBF	Chamber, Hyperbaric	Anesthesiology	868.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61959	Hyperbaric chamber, portable	A non-powered, portable device consisting of a large bag intended to contain a patient and to be inflated above ambient atmospheric pressure for the treatment of acute mountain sickness. The bag is inflated using a foot pump or air compressor, the internal pressure being controlled by an inlet/deflation valve; it is not intended to be used with enriched oxygen. The device is typically used by mountain climbers and athletes who train at high elevation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852834007003	GS1

Premarket Submissions

Submission Number	Supplement Number
K051759	000