FDA.reportPublic FDA data

Pentair

Primary DI
B462DDF4700T100C5
Brand
Pentair
Company
PENTAIR FILTRATION SOLUTIONS, LLC
Model
DDF4700T100C
Catalog number
DDF4700T100C
Published
2020-12-07
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
B462DDF4700T100C5PrimaryHIBCC0
B462DDF4700T100C0Unit 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
1000
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
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
B462DDF4711T100Y0PentairDDF4711T100Y DDF4711T100Y 2021-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10889483590591AirLife™AirLife Finland OyCAH2025-04-02
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
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000Dynarex CorporationCAH2021-04-22
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000Dynarex CorporationCAH2021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500Dynarex CorporationCAH2021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500Dynarex CorporationCAH2021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600Dynarex CorporationCAH2021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) FilterDynarex CorporationCAH2021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305861Resp-O2 Advantage Respiratory B/V FilterDynarex CorporationCAH2021-04-22
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex TubeDynarex CorporationCAH2021-04-22
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02