AccessGUDID - DEVICE: OxyMask™ (10620974001178)

GUDID

Device Identifier (DI) Information

Brand Name: OxyMask™
Version or Model: OM-2125-8SLM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OM-2125-8SLM
Company Name: Southmedic Incorporated

Primary DI Number: 10620974001178
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 246848147 *Terms of Use

Device Description: OxyMask ETCO2, 7ft oxygen tubing, 8ft sampling line with male connector

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?
61834	Breathing circuit gas-sampling/monitoring set	A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: OxyMask ETCO2, 7ft oxygen tubing, 8ft sampling line with male connector

Device Record Status

Public Device Record Key: 1887d126-bd12-4416-b489-fcb653387547
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016