Eagle Eye Platinum ST RX Digital IVUS Catheter 85900PST

GUDID 00845225003371

Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter

Philips Image Guided Therapy Corporation

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 00845225003371
• NIH Device Record Key: e2d123f8-4281-41d9-aaa6-50b0ecb8dc6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eagle Eye Platinum ST RX Digital IVUS Catheter
• Version Model Number: 85900PST
• Catalog Number: 85900PST
• Company DUNS: 118354223
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• 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
• 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
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com

Device Dimensions

• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0
• Length: 150 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between -20.2 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225003371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143701

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-02
• Device Publish Date: 2025-09-24

Devices Manufactured by Philips Image Guided Therapy Corporation

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• 00845225003364 - Eagle Eye Platinum RX Digital IVUS Catheter: 2025-10-02 Eagle Eye Platinum rapid exchange digital intravascular ultrasound catheter
• 00845225003371 - Eagle Eye Platinum ST RX Digital IVUS Catheter: 2025-10-02Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter
• 00845225003371 - Eagle Eye Platinum ST RX Digital IVUS Catheter: 2025-10-02 Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter
• 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