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Hybrid

FDA UDI

Class II (US FDA UDI)

by Innomed Technologies

Identity

Trade Name
Hybrid FDA UDI
Generic Name
CPAP/BPAP oral mask FDA UDI
Device Name
Hybrid Cushion- LG FDA UDI
Model / Reference
HYB515 FDA UDI
Description
Hybrid Cushion- LG FDA UDI

Identifiers

Catalog Number
HYB515 FDA UDI
Primary DI / UDI-DI
00833224000163 FDA UDI
FDA Product Code
BZD FDA UDI
GMDN Term
CPAP/BPAP oral mask FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Category: CPAP/BPAP oral mask

Hybrid by Innomed Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP oral mask.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innomed Technologies

Sources (1)

  • FDA UDI 42420974-eb11-4b49-8434-6cd625208941 35 fields · synced May 29, 2026