o_two e500 - o_two e500 is electronically controlled, - O-Two Medical Technologies Inc

Duns Number:206449154

Device Description: o_two e500 is electronically controlled, pneumatically powered ventilators with a AC/DC po o_two e500 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 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 100 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support.

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More Product Details

Catalog Number

01EVE500

Brand Name

o_two e500

Version/Model Number

01EVE500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141595,K141595

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

1ad6e640-4417-446f-ad47-cfb03d1aa64a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"O-TWO MEDICAL TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 48
U Unclassified 3