AccessGUDID - DEVICE: O-Two (07540195005181)

GUDID

Device Identifier (DI) Information

Brand Name: O-Two
Version or Model: 01CV8016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01CV8016-CS
Company Name: O-Two Medical Technologies Inc

Primary DI Number: 07540195005181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206449154 *Terms of Use

Device Description: The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8016 is specifically designed for use with CAREvent MRI ventilators and is long enough to allow free passage of the patient in and out of the MRI unit without the risk of pulling on the tubing.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37706	Ventilator breathing circuit, single-use	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Feet

Device Record Status

Public Device Record Key: 26a36a84-a180-4b30-a78d-a6c3eb1a36e8
Public Version Date: October 24, 2022
Public Version Number: 3
DI Record Publish Date: May 31, 2019