FDA.reportPublic FDA data

Pentair

Primary DI
B46200080020235
Brand
Pentair
Company
PENTAIR FILTRATION SOLUTIONS, LLC
Model
0008002023
Catalog number
DPC2023S500C
Published
2017-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRJFilter, Prebypass, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRJFilter, Prebypass, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982385000POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.1999-02-01KRJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B46200080020235PrimaryHIBCC0
B46200080020230Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system filter, priming solutionA porous, sterile device intended to be used to filter the nonhaemic priming solution used in the heart-lung bypass extracorporeal circuit to remove particulates or other debris from the circuit prior to the initiation of the cardiopulmonary bypass surgery procedure. 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
100
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
B462DPC2022S500C5PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2026-01-12
B462DPB3033PES002YV3PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2023-01-20
B4624150002205PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2021-03-26
B4624150002215PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2021-03-26
B4624150002200PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2021-03-26
B4624150002210PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2021-03-26
B462DPB3033PES002YN3PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2020-12-07
B462DPB3033PES002YN0PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2020-12-07
B4620008810893PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2018-11-07
B4627010210393PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2018-11-07
B4627010210403PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2018-11-07
B4627010310843PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2018-11-07
B4627010310863PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2018-11-07
B4620170169013PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2018-01-04
B46200080020115PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46200080020125PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46200080020225PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46200080020335PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4620008012125PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4620008038123PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4620008038383PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4620170169005PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4620170169025PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4620302183PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46210210393PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46210210403PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46210310843PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B46210310863PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4623452600003PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31
B4623452700003PentairPENTAIR FILTRATION SOLUTIONS, LLCKRJ2017-12-31