| 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 |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com | |
| Phone | (800) 228-4728 |
| IGTD.CustomerInquiry@philips.com |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| Length | 150 Centimeter |
| Device Size Text, specify | 0 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00845225003319 [Primary] |
| OBJ | Catheter, Ultrasound, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-02 |
| Device Publish Date | 2025-09-24 |
| 00845225003319 - Visions PV .014P RX Digital IVUS Catheter | 2025-10-02Visions PV .014P rapid exchange digital intravascular ultrasound catheter |
| 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 |
| 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 |