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OxyTyke™

FDA UDI

Class II (US FDA UDI)

by Southmedic Incorporated

Identity

Trade Name
OxyTyke™ FDA UDI
Generic Name
Vortex oxygen face mask FDA UDI
Device Name
OxyTyke Pediatric Aerosol Mask with 22 mm elbow Non-Painted FDA UDI
Model / Reference
OTN-1025 FDA UDI
Description
OxyTyke Pediatric Aerosol Mask with 22 mm elbow Non-Painted FDA UDI

Identifiers

Catalog Number
OTN-1025 FDA UDI
Primary DI / UDI-DI
10620974000515 FDA UDI
510(k) Number
K760489 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Vortex oxygen face mask FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 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

No

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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vortex oxygen face mask.

Cleared under the same submission

K760489 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Southmedic Incorporated

Sources (1)

  • FDA UDI 4aeae683-6d0f-4421-8bca-e016cdbe4ea1 37 fields · synced May 30, 2026