o_two e500

Primary DI
07540195033054
Brand
o_two e500
Company
O-Two Medical Technologies Inc
Model
01EVE500
Catalog number
01EVE500
Device description
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.
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141595000O-TWO E700,O-TWO E600,O-TWO E500O-Two Medical Technologies, Inc.2015-03-16BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540195033047Direct MarkingGS10
07540195033054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540195033047075401950330477540195033047
07540195033054075401950330547540195033054

GMDN Terms#

Term, Definition table
TermDefinition
Transport electric ventilatorAn electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height155Millimeter
Length200Millimeter
Length250Millimeter
Weight2.4Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07540195060111O-TWO 01RO01O10-B2023-06-06
07540195060241O-TWO 01RO01O23-B2023-06-06
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07540195005174O-Two01CV801501CV8015-CS2019-05-31
07540195005181O-Two01CV801601CV8016-CS2019-05-31
07540195005211O-Two01CV801901CV8019-CS2019-05-31
07540195005334O-Two01CV803001CV8030-CS2019-05-31
07540195005129O-Two01CV801001CV8010-CS2019-05-31
07540195071308O-Two02RT101002RT1010-CS2019-10-31
07540195071322O-Two02RT101202RT1012-CS2019-10-31

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Primary DI, Brand, Company table
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