O-Two Disposable Pressure manometer 0-20cmH2O 01CV8066

GUDID 17540195037004

O-Two Disposable Pressure Manometer is intended for use where monitoring airway pressure is desired. This device provides a visual indication of air w

O-Two Medical Technologies Inc

Airway pressure monitor, non-powered

• Primary Device ID: 17540195037004
• NIH Device Record Key: a77e4baa-2d2b-4729-96a3-b188822f41ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Two Disposable Pressure manometer 0-20cmH2O
• Version Model Number: 01CV8066
• Catalog Number: 01CV8066
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195037007 [Primary]
GS1	17540195037004 [Package]; Contains: 07540195037007; Package: Packaging box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102377

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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