FDA.reportPublic FDA data

CPAP Kit

Primary DI
00848530001322
Brand
CPAP Kit
Company
Sunset Healthcare Solutions, Inc.
Model
AMED049Combo
Device description
PR System One Remstar COMBO PACK **6 CF1009NT 1 CF1009F**
Published
2024-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRLUnit, Filter, Membrane

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRLUnit, Filter, MembraneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530001322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530001322008485300013228485300013220848530001322

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP unit ambient air filter, reusableA 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 reusable device.

Contacts#

Phone, Email table
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14
00848530110024Oxygen KitADAPTO2SFTKIT2026-10-14
00848530110048Ventilator FilterVF010F-502026-10-14
00848530108885Breathing CircuitVC1002-R2026-10-12
00848530108892Breathing CircuitVC1002P-R2026-10-12
00848530109882CPAP FilterCF2111HA-10PL2026-09-30
00848530109899CPAP FilterCF2107HA-10PL2026-09-30
00848530109905Oxygen KitRESO2KITAZPL2026-09-30
00848530109912Nebulizer and CompressorACTNEB1002026-09-30
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109790Ventilator FilterSunset Healthcare Solutions, Inc.JRL2026-10-19
00848530110031Ventilator FilterSunset Healthcare Solutions, Inc.JRL2026-10-19
00084853011017CPAP FilterSunset Healthcare Solutions, Inc.JRL2026-10-14
00848530109745CPAP FilterSunset Healthcare Solutions, Inc.JRL2026-10-14
00848530109844CPAP FilterSunset Healthcare Solutions, Inc.JRL2026-10-14
00848530110048Ventilator FilterSunset Healthcare Solutions, Inc.JRL2026-10-14
00848530109882CPAP FilterSunset Healthcare Solutions, Inc.JRL2026-09-30
00848530109899CPAP FilterSunset Healthcare Solutions, Inc.JRL2026-09-30
00084853000905Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.JRL2025-06-18
00848530031046CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-16
00848530032753CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-16
00789091681618CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-13
00789091681625CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-13
00848530001261CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030346CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030728CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030902CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030957CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530031435CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032043CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032050CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032098CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032159CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032685CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032692CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032708CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032715CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032722CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032739CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032746CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26