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 ID: 07540195054004
• NIH Device Record Key: aed30418-1752-498e-8e62-deff527ac2b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fingertip Pulse Oximeter
• Version Model Number: 01MN1000
• Catalog Number: 01MN1000
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com
• Phone: 1-800-387-3405
• Email: cs@otwo.com

Device Dimensions

• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter
• Weight: 28 Gram
• Height: 32 Millimeter
• Width: 34 Millimeter
• Length: 58 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195054004 [Primary]
GS1	17540195054001 [Package]; Package: Pouch and Box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070371

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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 Nox: 2023-11-21 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