FDA.reportPublic FDA data

Patient Interface Module (PIMr)

Primary DI
00845225011420
Brand
Patient Interface Module (PIMr)
Company
Philips Image Guided Therapy Corporation
Model
808884001
Catalog number
808884001
Device description
Patient interface module for rotational intravascular ultrasound catheters
Published
2025-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSKComputer, Blood-Pressure
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSKComputer, Blood-PressureCardiovascular2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071554000
K190078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071554000VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEMVolcano Corporation2008-01-04OBJ
K190078000IntraSightVolcano Corporation2019-02-11DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225011420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225011420008452250114208452250114200845225011420

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius62 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
018860556
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225012939IntraSight Plus7974177974172026-05-26
00845225012946IntraSight Plus7974237974232026-05-26
00813132028824StellarexAB35SX040040080AB35SX0400400802022-01-05
00813132028763StellarexAB35SX060100135AB35SX0601001352022-01-13
00813132028770StellarexAB35SX040100135AB35SX0401001352022-01-13
00813132028787StellarexAB35SX040100080AB35SX0401000802022-01-13
00813132028794StellarexAB35SX050100080AB35SX0501000802022-01-13
00813132028800StellarexAB35SX060100080AB35SX0601000802022-01-13
00813132028817StellarexAB35SX050100135AB35SX0501001352022-01-13
00813132028831StellarexAB35SX040080080AB35SX0400800802022-01-13
00813132028848StellarexAB35SX040120080AB35SX0401200802022-01-13
00813132028855StellarexAB35SX050040080AB35SX0500400802022-01-13
00813132028862StellarexAB35SX050080080AB35SX0500800802022-01-13
00813132028879StellarexAB35SX050120080AB35SX0501200802022-01-13
00813132028886StellarexAB35SX060040080AB35SX0600400802022-01-13
00813132028893StellarexAB35SX060080080AB35SX0600800802022-01-13
00813132028909StellarexAB35SX060120080AB35SX0601200802022-01-13
00813132028916StellarexAB35SX040040135AB35SX0400401352022-01-13
00813132028923StellarexAB35SX040080135AB35SX0400801352022-01-13
00813132028930StellarexAB35SX040120135AB35SX0401201352022-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09