o_two e600

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: o_two e600 FDA UDI
Generic Name: Transport electric ventilator FDA UDI
Device Name: o_two e600 is electronically controlled, pneumatically powered ventilators with a AC/DC power adapter and an internal rechargeable Lithium Ion battery pack used to power the electronics, intended for use during transport to provide resuscitation and/or ventilatory support to wide range of patients in respiratory distress or arrest. It is a time-cycled, volume-constant emergency and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child and infant patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support. FDA UDI
Model / Reference: 01EVE600 FDA UDI
Description: o_two e600 is electronically controlled, pneumatically powered ventilators with a AC/DC power adapter and an internal rechargeable Lithium Ion battery pack used to power the electronics, intended for use during transport to provide resuscitation and/or ventilatory support to wide range of patients in respiratory distress or arrest. It is a time-cycled, volume-constant emergency and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child and infant patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support. FDA UDI

Identifiers

Catalog Number: 01EVE600 FDA UDI
Primary DI / UDI-DI: 07540195033030 FDA UDI
510(k) Number: K141595 FDA UDI
FDA Product Code: BTL FDA UDI
GMDN Term: Transport electric ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5925 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: Weight — 2.4 Kilogram FDA UDI
Height — 155 Millimeter FDA UDI
Width — 200 Millimeter FDA UDI
Length — 250 Millimeter FDA UDI

Category: Transport electric ventilator

o_two e600 by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K141595 also covers:

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: O-Two Medical Technologies Inc

Sources (1)

FDA UDI ddcc813f-47f9-44b8-8ffc-74e4d31abdd0 38 fields · synced May 29, 2026