o_two e700

Primary DI
07540195033009
Brand
o_two e700
Company
O-Two Medical Technologies Inc
Model
01EVE700
Catalog number
01EVE700
Device description
o_two e700 is electronically controlled, pneumatically powered ventilators with a AC/DC power adapter and an internal rechargeable Lithium Ion battery
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07540195033009Direct MarkingGS10
07540195033016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540195033009075401950330097540195033009
07540195033016075401950330167540195033016

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
Length250Millimeter
Weight2.4Kilogram
Width200Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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07540195050075O-Two 01FCO125D2023-11-07
07540195035157O-Two 01CV02202023-06-22
17540195035154O-Two 01CV02202023-06-22
07540195060111O-TWO 01RO01O10-B2023-06-06
07540195060241O-TWO 01RO01O23-B2023-06-06
07540195086616O-TWO 01RN09N10-B2023-06-06
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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