DEVICE: OxyTyke™ (10620974000508)
Device Identifier (DI) Information
OxyTyke™
OT-7025-8
In Commercial Distribution
OT-7025-8
Southmedic Incorporated
OT-7025-8
In Commercial Distribution
OT-7025-8
Southmedic Incorporated
OxyTyke Non PVC with 7ft tubing
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BYG | MASK, OXYGEN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c76b1232-9aed-44c7-b8d4-a3a874b5d7c8
December 28, 2020
1
December 18, 2020
December 28, 2020
1
December 18, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00620974000501
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(705)726-9383
custserv@southmedic.com
custserv@southmedic.com