FDA.reportPublic FDA data

Plastic Intake Nebulizer Filter - with Head

Primary DI
00848530010119
Brand
Plastic Intake Nebulizer Filter - with Head
Company
Sunset Healthcare Solutions, Inc.
Model
BF016-1
Catalog number
BF016-1
Device description
Sunset Healthcare Solutions Plastic Intake Nebulizer Filter - with Head
Published
2018-05-24
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
00848530010119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530010119008485300101198485300101190848530010119

GMDN Terms#

Term, Definition table
TermDefinition
Suction system filter, microbialA screening device intended to be installed within a suction system and which has a membrane pore size small enough to retain bacterial pathogens, thus preventing the environment from becoming infected and decreasing the risk of cross-infection to subsequent patients. It is typically directly connected to the suction system collection bottle/canister, or as a common filter serving more than one bottle/canister through a switching mechanism, or in a tubing line between the suction bottle/canister and the suction pump, or at the suction pump exhaust where driving gases are discarded. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00848530032760CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032777CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032791CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032807CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032814CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032821CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032838CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030094CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-25