Oxygen Demand Valve 01DV3000

GUDID 07540195020115

The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distress at the flow rate demanded by the patient.

O-Two Medical Technologies Inc

Demand valve
Primary Device ID07540195020115
NIH Device Record Key5aba5d3b-90f3-4462-8cc3-749cd7f3f270
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxygen Demand Valve
Version Model Number01DV3000
Catalog Number01DV3000
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

Weight0.2 Kilogram
Height3.1 Inch
Outer Diameter2 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195020115 [Direct Marking]
GS107540195020122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (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 Date2015-10-26

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