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Zoey CPAP Cleaner

FDA UDI

Class II (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
Zoey CPAP Cleaner FDA UDI
Generic Name
Home CPAP/BPAP washer-disinfector (ozone) FDA UDI
Device Name
CPAP Cleaning Device FDA UDI
Model / Reference
ZCD100 FDA UDI
Description
CPAP Cleaning Device FDA UDI

Identifiers

Catalog Number
ZCD100 FDA UDI
Primary DI / UDI-DI
00848530090890 FDA UDI
FDA Product Code
MEC FDA UDI
GMDN Term
Home CPAP/BPAP washer-disinfector (ozone) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6992 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Home CPAP/BPAP washer-disinfector (ozone)

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

Similar devices

Also classified as Home CPAP/BPAP washer-disinfector (ozone).

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 3bf24a8d-c201-4111-bd22-54a7da03b08d 35 fields · synced May 30, 2026