← Back to catalogue

Bacteria Filter

FDA UDI

Class I (US FDA UDI)

by SUNSET HEALTHCARE SOLUTIONS, Inc.

Identity

Trade Name
Bacteria Filter FDA UDI
Generic Name
CPAP/BPAP unit ambient air filter, single-use FDA UDI
Device Name
3B Stratus 5 O2 Concentrator HEPA Filter - Each FDA UDI
Model / Reference
BF6020 FDA UDI
Description
3B Stratus 5 O2 Concentrator HEPA Filter - Each FDA UDI

Identifiers

Primary DI / UDI-DI
00848530099749 FDA UDI
FDA Product Code
BYX FDA UDI
GMDN Term
CPAP/BPAP unit ambient air filter, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

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

Bacteria Filter 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 e741e55d-ee6b-42a1-9ad3-a555d7c1f3a6 34 fields · synced May 30, 2026