Patient Interface Module (PIMr) 808884001

GUDID 00845225012984

Patient interface module for rotational intravascular ultrasound catheters

Philips Image Guided Therapy Corporation

Cardiovascular ultrasound imaging system

• Primary Device ID: 00845225012984
• NIH Device Record Key: 02ee426f-86c2-4e31-a18b-528d00bec53a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Interface Module (PIMr)
• Version Model Number: 808884001
• Catalog Number: 808884001
• Company DUNS: 018860556
• Company Name: Philips Image Guided Therapy Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Caution: Contents Static Sensitive
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Caution: Contents Static Sensitive
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Caution: Contents Static Sensitive

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225012984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190078

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-01
• Device Publish Date: 2025-08-22

Devices Manufactured by Philips Image Guided Therapy Corporation

• 00845225012984 - Patient Interface Module (PIMr): 2025-09-01Patient interface module for rotational intravascular ultrasound catheters
• 00845225012984 - Patient Interface Module (PIMr): 2025-09-01 Patient interface module for rotational intravascular ultrasound catheters
• 00845225003425 - Pioneer Plus Catheter: 2024-08-20
• 20813132029412 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029429 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029436 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029443 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029450 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 00813132029463 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter