← Back to catalogue

Breeze Quiet One Kit

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
Breeze Quiet One Kit FDA UDI
Generic Name
CPAP/BPAP unit ambient air filter, single-use FDA UDI
Device Name
This kit contains: 2 OF1005 Foam Cabinet Filters, 1 BF316 Final Bacteria Filter, 1 BFH6S 6in HEPA Capsule FDA UDI
Model / Reference
OF11001SP FDA UDI
Description
This kit contains: 2 OF1005 Foam Cabinet Filters, 1 BF316 Final Bacteria Filter, 1 BFH6S 6in HEPA Capsule FDA UDI

Identifiers

Catalog Number
OF11001SP FDA UDI
Primary DI / UDI-DI
00848530051198 FDA UDI
FDA Product Code
JRL FDA UDI
GMDN Term
CPAP/BPAP unit ambient air filter, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: CPAP/BPAP unit ambient air filter, single-use

Breeze Quiet One Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CPAP/BPAP unit ambient air filter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
SUNSET HEALTHCARE SOLUTIONS, Inc.

Sources (1)

  • FDA UDI 45385061-cf37-477b-b079-f95e53959a04 35 fields · synced May 30, 2026