Visions PV .014P RX Digital IVUS Catheter 014R

GUDID 00845225003319

Visions PV .014P rapid exchange digital intravascular ultrasound catheter

Philips Image Guided Therapy Corporation

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 00845225003319
• NIH Device Record Key: 87d03e6e-bb0c-4ceb-8a8c-5d16ce7491a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visions PV .014P RX Digital IVUS Catheter
• Version Model Number: 014R
• Catalog Number: 014R
• 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	00845225003319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152829

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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• 00845225003319 - Visions PV .014P RX Digital IVUS Catheter: 2025-10-02 Visions PV .014P rapid exchange digital intravascular ultrasound catheter
• 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: 2025-10-02 Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter
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• 00845225003425 - Pioneer Plus Catheter: 2024-08-20
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• 20813132029429 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029436 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter