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CPAP Masks

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
CPAP Masks FDA UDI
Generic Name
CPAP/BPAP face mask, reusable FDA UDI
Device Name
Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Large FDA UDI
Model / Reference
CM041L FDA UDI
Description
Sunset Full Face Mask, Standard Elbow, with Standard Headgear, Large FDA UDI

Identifiers

Primary DI / UDI-DI
00848530097325 FDA UDI
FDA Product Code
BZD FDA UDI
GMDN Term
CPAP/BPAP face mask, reusable 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CPAP/BPAP face mask, reusable

CPAP Masks by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP face mask, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI 43c0fb75-bcac-43b2-9bfa-022ec35fafaa 34 fields · synced May 31, 2026