FDA.reportPublic FDA data

Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 50/Pack

Primary DI
00848530010843
Brand
Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 50/Pack
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
BF2200-50
Catalog number
BF2200-50
Device description
Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 50/Pack
Published
2016-09-23
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530010843PrimaryGS10
10848530010840Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530010843008485300108438485300108430848530010843
1084853001084010848530010840

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter15Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
50
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
30889483228108Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228115Cardinal HealthSUNMED, LLCCAH2025-12-31
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30889483228146Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228153Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228160Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228177Cardinal HealthSUNMED, LLCCAH2025-12-31
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20889483234195Vital Signs™SUNMED, LLCCAH2025-12-30
20889483221188Vital Signs™SUNMED, LLCCAH2025-12-23
20889483222543Vital Signs™SUNMED, LLCCAH2025-12-23
20889483226787Vital Signs™SUNMED, LLCCAH2025-12-23
20889483230487Vital Signs™SUNMED, LLCCAH2025-12-23
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