FDA.reportPublic FDA data

Pentair

Primary DI
B462DBF32K045
Brand
Pentair
Company
PENTAIR FILTRATION SOLUTIONS, LLC
Model
DBF32K04
Catalog number
DBF32K04
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061426000OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47Porous Media Corp.2006-06-05CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B462DBF32K045PrimaryHIBCC0
B462DBF32K040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Microbial medical gas filter, single-useA screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-759-6693efcustomerservice@pentair.com

Regulatory Flags#

DUNS number
057656759
Device count
250
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B462DPC2022S500C5PentairDPC2022S500CDPC2022S500C2026-01-12
B462IVC11312493PentairIVC1131249DBF25C2024-08-30
B462IVC11312490PentairIVC1131249DBF25C2024-08-30
B4624150010001Pentair415001000DDF4700T100C2024-02-26
B4624150010003Pentair415001000DDF4700T100C2024-02-26
B462DBF32K043PentairDBF32K04DBF32K042024-02-26
B462DBF32K040PentairDBF32K04DBF32K042024-02-26
B462DDF4700M02YHP5PentairDDF4700M02YHPDDF4700M02YHP2023-01-20
B462DPB3033PES002YV3PentairDPB3033PES002YVDPB3033PES002YV2023-01-20
B462DDF4700M02C5PentairDDF4700M02C DDF4700M02C 2021-05-03
B462DDF4700M02Y5PentairDDF4700M02Y DDF4700M02Y 2021-05-03
B462DDF4700M03Y5PentairDDF4700M03Y DDF4700M03Y 2021-05-03
B462DDF4711T100K5PentairDDF4711T100K DDF4711T100K 2021-05-03
B462DDF4711T100Y5PentairDDF4711T100Y DDF4711T100Y 2021-05-03
B462DDF4739T100Y5PentairDDF4739T100Y DDF4739T100Y 2021-05-03
B462DDF4700M02C0PentairDDF4700M02C DDF4700M02C 2021-05-03
B462DDF4700M03Y0PentairDDF4700M03Y DDF4700M03Y 2021-05-03
B462DDF4711T100K0PentairDDF4711T100K DDF4711T100K 2021-05-03
B462DDF4711T100Y0PentairDDF4711T100Y DDF4711T100Y 2021-05-03
B462DDF4739T100Y0PentairDDF4739T100Y DDF4739T100Y 2021-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02
10190752139589Vital Signs™AirLife Finland OyCAH2021-04-02
10190752135987Vital Signs™AirLife Finland OyCAH2021-03-05
10190752135994Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136632Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136793Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136809Vital Signs™AirLife Finland OyCAH2021-03-05
10190752138094Vital Signs™VYAIRE MEDICAL, INC.CAH2021-03-05
10190752139107Vital Signs™AirLife Finland OyCAH2021-03-05
10190752139558Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140080Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140097AirLife™AirLife Finland OyCAH2021-03-05
10190752136724Vital SignsAirLife Finland OyCAH2021-03-01
10190752147171AirLife™AIRLIFECAH2020-02-04
10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04