FDA.reportPublic FDA data

Pentair

Primary DI
B4624150002200
Brand
Pentair
Company
PENTAIR FILTRATION SOLUTIONS, LLC
Model
415000220
Catalog number
DPC2023S500C
Published
2021-03-26
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
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
B4624150002205PrimaryHIBCC0
B4624150002200Unit 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
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
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
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
B46200080020235PentairPENTAIR 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