FDA.reportPublic FDA data

Pentair

Primary DI
B462DBF32K040
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
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

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
B462DBF32K043PrimaryHIBCC0
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057656759
Device count
250
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
B462DPC2022S500C5PentairDPC2022S500CDPC2022S500C2026-01-12
B462IVC11312493PentairIVC1131249DBF25C2024-08-30
B462IVC11312490PentairIVC1131249DBF25C2024-08-30
B4624150010001Pentair415001000DDF4700T100C2024-02-26
B4624150010003Pentair415001000DDF4700T100C2024-02-26
B462DBF32K043PentairDBF32K04DBF32K042024-02-26
B462DBF32K045PentairDBF32K04DBF32K042024-02-26
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