PressureWire™ C12358
GUDID 05414734055819
Guidewire Mounted Sensor
ST. JUDE MEDICAL, INC.
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| NIH Device Record Key | 9904cf3e-0d72-40fb-9414-524d3cd0f3a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PressureWire™ |
| Version Model Number | C12358 |
| Catalog Number | C12358 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
| Length | 300 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734055819 [Primary] |
| GS1 | 15414734055816 [Package] Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140466
FDA Product Code
| DRG | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2015-12-09 |
On-Brand Devices [PressureWire™]
| 15415067025743 | Guidewire |
| 15415067025736 | Guidewire |
| 05415067025722 | Guidewire |
| 15415067025712 | Guidewire |
| 05415067000118 | Signal Receiver Kit |
| 15414734055816 | Aeris™ Agile Tip |
| 15414734055793 | Certus™ Agile Tip |
| 15414734055779 | Aeris™ Agile Tip |
| 15414734055755 | Certus™ Agile Tip |
| 05414734055734 | Monitor Cable |
| 05414734054690 | Monitor Cable |
| 05414734051972 | Monitor Cable |
| 05414734051965 | Monitor Cable |
| 05414734051958 | Monitor Cable |
| 05414734051941 | Monitor Cable |
| 05414734051927 | Monitor Cable |
| 05414734051910 | Monitor Cable |
| 05414734051897 | Monitor Cable |
| 05414734051804 | Monitor Cable |
| 05414734051774 | Monitor Cable |
| 05414734051743 | Monitor Cable |
| 05414734051729 | Monitor Cable |
| 05414734051712 | Monitor Cable |
| 05414734051699 | Monitor Cable |
| 05414734051651 | Monitor Cable |
| 05414734051620 | Monitor Cable |
| 05414734051606 | Cable |
| 05414734051576 | Monitor Cable |
| 05414734051569 | Monitor Cable |
| 05414734050937 | Monitor Cable |
| 05414734055819 | Guidewire Mounted Sensor |
| 05414734055796 | Guidewire Mounted Sensor |
| 05414734055772 | Guidewire Mounted Sensor |
| 05414734055758 | Guidewire Mounted Sensor |
| 05414734051422 | Cable |
Trademark Results [PressureWire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRESSUREWIRE 75786514 2590269 Live/Registered |
ST. JUDE MEDICAL COORDINATION CENTER BVBA 1998-08-04 |
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