PerforMax

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: PerforMax FDA UDI
Generic Name: CPAP/BPAP face mask, single-use FDA UDI
Device Name: Performax Mask, with Standard Elbow, Single Use, Large FDA UDI
Model / Reference: Performax Mask, Single Use w/SE, Large FDA UDI
Description: Performax Mask, with Standard Elbow, Single Use, Large FDA UDI

Identifiers

Catalog Number: 1061622 FDA UDI
Primary DI / UDI-DI: 00606959007710 FDA UDI
510(k) Number: K092648 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: CPAP/BPAP face mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: CPAP/BPAP face mask, single-use

PerforMax by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as CPAP/BPAP face mask, single-use.

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BiTrac SE Select — Pulmodyne Inc. · Class II
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Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult — Sleepnet Corporation · Class II
Novaplus Full Face Non Vented Mask, Medium — Sleepnet Corporation · Class II
BiTrac Select — Pulmodyne Inc. · Class II
BiTrac SE Select — Pulmodyne Inc. · Class II

Cleared under the same submission

K092648 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Respironics, Inc.

Sources (1)

FDA UDI cba534b3-bdaa-46cf-a741-c54614d797fd 37 fields · synced May 30, 2026