FDA.reportPublic FDA data

Disc Filter

Primary DI
04719875918087
Brand
Disc Filter
Company
AEON BIOTHERAPEUTICS CORP.
Model
B00130001
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
04719875918087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875918087047198759180874719875918087

GMDN Terms#

Term, Definition table
TermDefinition
Hydrophobic Luer filterA device intended to be attached to equipment during a medical/surgical procedure and/or to a needle during drug preparation (i.e., vial venting) to prevent the transfer of microbes, particulates and aerosols while allowing passage of air/gas; its use is not dedicated to a specific type of medical equipment. It is a small plastic housing containing a hydrophobic filter with male and female Luer connections (Luer-lock or Luer-slip). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656153288
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719875912283Virtue ACKitACK-152026-09-24
04719875912290Virtue ACKitACK-D15P2026-09-24
04719875912306Virtue ACKitPL-152026-09-24
04719875912276Virtue ACKitACK-15P2026-06-22
04719875912122Virtue CPKitAPA-152025-05-15
04719875912139Virtue CPKitAPA-15D2025-05-15
04719875912146Virtue CPKitAPA-15G2025-05-15
04719875912153Virtue CPKitAPA-10G2025-05-15
04719875912160Virtue CPKitABA-15S2025-05-15
04719875912177Virtue CPKitABA-15Q2025-05-15
04719875912030Aeon CPKitABA-15S2024-03-19
04719875912047Aeon CPKitABA-15Q2024-03-19
04719875912054Aeon CPKitAPA-15D2024-03-19
04719875912009Aeon CPKitAPA-152022-11-09
04719875912016Aeon CPKitAPA-15G2022-11-09
04719875912023Aeon CPKitAPA-10G2022-11-09
04719875912245Transcend PRPTP01002025-08-07
04719875912252Transcend PRPTP03002025-08-07
14719875912242Transcend PRPTP01002025-08-07
14719875912259Transcend PRPTP03002025-08-07

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