o_two e600 01EVE600

GUDID 07540195033030

o_two e600 is electronically controlled, pneumatically powered ventilators with a AC/DC power adapter and an internal rechargeable Lithium Ion battery

O-Two Medical Technologies Inc

Transport electric ventilator
Primary Device ID07540195033030
NIH Device Record Keyddcc813f-47f9-44b8-8ffc-74e4d31abdd0
Commercial Distribution StatusIn Commercial Distribution
Brand Nameo_two e600
Version Model Number01EVE600
Catalog Number01EVE600
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Device Dimensions

Weight2.4 Kilogram
Height155 Millimeter
Width200 Millimeter
Length250 Millimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195033023 [Direct Marking]
GS107540195033030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTLVentilator, Emergency, Powered (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

Devices Manufactured by O-Two Medical Technologies Inc

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17540195040073 - Pro Nox2023-11-21 The PRO NOX Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device de
07540195015012 - O-Two 2023-11-15 Nitrile Powder Free Gloves
07540195015029 - O-Two 2023-11-15 Supply Hose Assembly
07540195015036 - O-Two 2023-11-15 Supply Hose Assembly
07540195050051 - O-Two 2023-11-15 The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow cont
07540195050075 - O-Two 2023-11-15 FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice,
17540195035154 - O-Two 2023-06-30 O-Two Single-Use CPAP Nebulizer System c/w 6 L/min Flow Adapter, T-Piece, Updraft Nebulizer with Oxygen Supply Tubing

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