Fingertip Pulse Oximeter 01MN1000

GUDID 07540195054004

Fingertip Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric

O-Two Medical Technologies Inc

Pulse oximeter probe, reusable
Primary Device ID07540195054004
NIH Device Record Keyaed30418-1752-498e-8e62-deff527ac2b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFingertip Pulse Oximeter
Version Model Number01MN1000
Catalog Number01MN1000
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com
Phone1-800-387-3405
Emailcs@otwo.com

Device Dimensions

Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter
Weight28 Gram
Height32 Millimeter
Width34 Millimeter
Length58 Millimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195054004 [Primary]
GS117540195054001 [Package]
Package: Pouch and Box [15 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

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 Date2016-09-23

Devices Manufactured by O-Two Medical Technologies Inc

07540195020269 - O Two 2024-05-07 Demand Valve Resuscitator- FERNO O-Two Demand Valve Resuscitator comes standard with pressure relief system and audible alarm a
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.