FDA.reportPublic FDA data

CPAP Filter

Primary DI
00848530030902
Brand
CPAP Filter
Company
Sunset Healthcare Solutions, Inc.
Model
CF1006NS
Device description
Respironics REMstar Pro, REMstar Plus Style Ultrafine Filters Bulk
Published
2024-07-26
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
00848530030902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530030902008485300309028485300309020848530030902

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
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00848530110000Ventilator AccessoryVCMPV001-A2026-11-03
00848530110130Nasal CPAP MaskCM060-KITSLAB2026-11-03
00848530110147Oxygen KitCM060-KITLLAB2026-11-04
00848530110192CPAP MaskCM061SLAB2026-11-04
00848530110208CPAP MaskCM061MLAB2026-11-04
00848530110215CPAP MaskCM061LLAB2026-11-04
00848530110222CPAP MaskCM061XLLAB2026-11-04
00848530110284Oxygen KitAEAG002PKIT2026-11-03
00848530110291Oxygen KitAEAG002CKIT2026-11-03
00848530110307Breathing CircuitVEN004-CAP2026-11-03
00848530109875Ventilator accessoryVCMPV0012026-10-27
00848530110086Oxygen, Bacteria & HEPA FilterBF1412-32026-10-27
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

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
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
00848530030094CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-25