FDA.reportPublic FDA data

Pentair

Primary DI
B462IP3
Brand
Pentair
Company
PENTAIR FILTRATION SOLUTIONS, LLC
Model
IP
Catalog number
HMK-IP
Published
2017-12-31
Public version status
Update
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
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062091000POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATIONPorous Media Corp.2006-08-08BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B462IP3PrimaryHIBCC0
B462IP0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory line humidification chamber, single-useA non-sterile device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. 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
10
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

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