FDA.reportPublic FDA data

Pentair

Primary DI
B462IVC11312493
Brand
Pentair
Company
PENTAIR FILTRATION SOLUTIONS, LLC
Model
IVC1131249
Catalog number
DBF25C
Published
2024-08-30
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
B462IVC11312493PrimaryHIBCC0
B462IVC11312490Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-respiratory device ambient air filterA filter designed to be installed in a non-respiratory device to clean the ambient air that passes through it to facilitate device operation/management. It is composed of tightly woven materials which remove particulates/impurities and, depending on how the device is installed, reduce the concentration of impurities to or from the air. It is typically used in devices that draw in ambient air for use as part of their function (e.g., to cool electrical motors, liquidize air as in a flotation therapy bed, wash/disinfect surgical instruments), or devices that, having used the air as a drive gas, exhaust it into a room via the filter. After installation, this device cannot be reused.

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
126
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B462100053363Pentair10005336DBF23K0402026-08-21
B462100053393Pentair10005339DBF23K0412026-08-21
B462DPC2022S500C5PentairDPC2022S500CDPC2022S500C2026-01-12
B462IVC11312490PentairIVC1131249DBF25C2024-08-30
B4624150010001Pentair415001000DDF4700T100C2024-02-26
B4624150010003Pentair415001000DDF4700T100C2024-02-26
B462DBF32K043PentairDBF32K04DBF32K042024-02-26
B462DBF32K045PentairDBF32K04DBF32K042024-02-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-06-23
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
00848530089115Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089139Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089108Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530093839Cough Assist KitSunset Healthcare Solutions, Inc.CAH2025-05-21
00848530099503Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530092283Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530104511Oxygen FilterSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530104689Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105372Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105389Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
008485301044366IN HEPA Capsule with Removable StickerSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104863Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104672Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-04-21