FDA.report

CPAP Filter

Primary DI
00848530098322
Brand
CPAP Filter
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
ABUC001CF1012-2
Device description
Ultra Fine Filter Respironics DreamStation 2 Disposable Filter (2/Pack)
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JRLUnit, Filter, Membrane

Product Code Classifications

CodeDeviceSpecialtyClass
JRLUnit, Filter, MembraneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530098322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530098322008485300983228485300983220848530098322

GMDN Terms

TermDefinition
CPAP/BPAP unit ambient air filter, single-useA non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00848530108618CPAP FilterF-1382026-03-19
00848530108632CPAP TubingTUBE-962026-03-19
00848530108472Oxygen, Bacteria & HEPA FilterBF027-102026-03-17
00848530108489CPAP FilterA11FILTER12PK2026-03-17
10848530108646Repair PartsRP0972026-03-17
00848530108656Repair PartsRP0982026-03-17
10848530108660Repair PartsRP0992026-03-17
10848530108677Repair PartsRP1002026-03-17
10848530108684Repair PartsRP1042026-03-17
10848530108189Repair PartsRP1032026-03-09
10848530108196Repair PartsRP1052026-03-09
10848530108202Oxygen, Bacteria & HEPA FilterOF7003-102026-03-09
10848530108219Oxygen, Bacteria & HEPA FilterOF7005-102026-03-09
00848530108571Repair PartsRP101NS2026-03-09
00848530108588Repair PartsRP102NS2026-03-09
10848530108356Vented CPAP Masks VC10092026-03-03
10848530108363Vented CPAP Masks VC10102026-03-03
10848530108370Vented CPAP Masks VC10112026-03-03
10848530108387Vented CPAP Masks VC10122026-03-03
00848530108427Ventilator FilterVF005-12026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450834005MiniStop®Merit Medical Systems, Inc.JRL2026-03-20
00848530108618CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-19
00848530108472Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-17
00848530108489CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-17
10848530108202Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-09
10848530108219Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-09
00848530108427Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-02-20
00848530108465Bacteria FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-02-20
00848530108267Filter - VentSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-02-02
00848530108298CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-01-27
00848530108137CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-01-26
00848530107949CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107956CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107963CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107970CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107987CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107994CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
10848530108103Filter - VentSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107642CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-11-24
00848530107598CPAP FiltersSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-11-12
00848530107604CPAP FiltersSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-11-12
00848530107635CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-11-12
00848530050627Oxygen FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-11-04
00848530107307CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-09-11
00848530107314CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-09-11
00848530107192CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-08-13
00848530107253Filter - VentSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-08-13
00848530107260Filter - VentSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-08-13
04719875918087Disc FilterAEON BIOTHERAPEUTICS CORP.JRL2025-08-13
00848530106843Oxygen FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-08-06