AccessGUDID - DEVICE: OxyMask™ (10620974001369)

GUDID

Device Identifier (DI) Information

Brand Name: OxyMask™
Version or Model: OKMK-4025-8
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OKMK-4025-8
Company Name: Southmedic Incorporated

Primary DI Number: 10620974001369
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2020
Device Count: 25
Labeler D-U-N-S® Number*: 246848147 *Terms of Use

Device Description: OxyMulti Kid Ultra Kit with Nebulizer

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:	Yes
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?
58810	Vortex oxygen face mask	A non-sterile, form-shaped, fenestrated device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. It incorporates a pin/diffuser intended to create vortices of high-concentration O2 directed to the mouth and nose to provide the full range of FiO2 (fraction of inspired oxygen) required for oxygen therapy. The fenestration designed to prevent positive pressure build-up and rebreathing, also allows for easier communication/feeding. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer) is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K760489	000

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: OxyMulti Kid Ultra Kit with Nebulizer

Device Record Status

Public Device Record Key: c46dffc7-ce7e-43be-a3b3-24d8fa4fcbdc
Public Version Date: December 18, 2020
Public Version Number: 6
DI Record Publish Date: September 01, 2016