PAHI VersalVent

FDA UDI

Class II (US FDA UDI)

by Pan-America Hyperbarics, Inc.

Identity

Trade Name: PAHI VersalVent FDA UDI
Generic Name: Portable pneumatic ventilator FDA UDI
Device Name: The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when placed inside a monoplace hyperbaric chamber for prescribed therapy. FDA UDI
Model / Reference: Model V1 FDA UDI
Description: The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when placed inside a monoplace hyperbaric chamber for prescribed therapy. FDA UDI

Identifiers

Primary DI / UDI-DI: 04719872000006 FDA UDI
510(k) Number: K122560 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Portable pneumatic ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 241.3 Millimeter FDA UDI
Width — 203.2 Millimeter FDA UDI
Length — 304.8 Millimeter FDA UDI

Category: Portable pneumatic ventilator

PAHI VersalVent by Pan-America Hyperbarics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pan-America Hyperbarics, Inc.

Sources (1)

FDA UDI 8607f4b5-4fa4-49dc-88a5-360fe9796e9b 36 fields · synced May 30, 2026