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OxyTyke™

FDA UDI

Class I (US FDA UDI)

by Southmedic Incorporated

Identity

Trade Name
OxyTyke™ FDA UDI
Generic Name
Vortex oxygen face mask FDA UDI
Device Name
OxyTyke Pediatric Mask with 7ft tubing non-painted FDA UDI
Model / Reference
OT-1025-8 FDA UDI
Description
OxyTyke Pediatric Mask with 7ft tubing non-painted FDA UDI

Identifiers

Catalog Number
OT-1025-8 FDA UDI
Primary DI / UDI-DI
10620974000492 FDA UDI
FDA Product Code
BYG FDA UDI
GMDN Term
Vortex oxygen face mask FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vortex oxygen face mask

OxyTyke™ by Southmedic Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vortex oxygen face mask.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Southmedic Incorporated

Sources (1)

  • FDA UDI c89907e1-c8cf-4de3-b6a7-02f2d78798b4 35 fields · synced May 31, 2026