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US Hyperbaric Network

FDA UDI

Class II (US FDA UDI)

by Us Hyperbaric Network

Identity

Trade Name
US Hyperbaric Network FDA UDI
Generic Name
Hyperbaric chamber, stationary FDA UDI
Device Name
The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi-rigid chamber for low pressures (operating at pressures of no greater than 1.5 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012). FDA UDI
Model / Reference
430+ FDA UDI
Description
The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi-rigid chamber for low pressures (operating at pressures of no greater than 1.5 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012). FDA UDI

Identifiers

Primary DI / UDI-DI
G623430 FDA UDI
510(k) Number
K220290 FDA UDI
FDA Product Code
CBF FDA UDI
GMDN Term
Hyperbaric chamber, stationary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Hyperbaric chamber, stationary

US Hyperbaric Network by Us Hyperbaric Network — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperbaric chamber, stationary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Us Hyperbaric Network

Sources (1)

  • FDA UDI 11e142e4-acbc-4476-b79e-ccaeeb7e9cdd 35 fields · synced May 31, 2026