IonicRF™ RFG-IONIC
GUDID 05415067029317
Generator
ST. JUDE MEDICAL, INC.
Radio-frequency ablation system generator| Primary Device ID | 05415067029317 |
| NIH Device Record Key | dc291efb-e0e7-4dd1-8f1c-f5450fe4d475 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IonicRF™ |
| Version Model Number | RFG-IONIC |
| Catalog Number | RFG-IONIC |
| 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 | 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 | +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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067029317 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201610
FDA Product Code
| GXD | Generator, lesion, radiofrequency |
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 | 2020-12-22 |
| Device Publish Date | 2020-12-14 |
On-Brand Devices [IonicRF™]
| 05415067033833 | Generator Pole Mount |
| 05415067029317 | Generator |
Trademark Results [IonicRF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IONICRF 88629092 not registered Live/Pending |
St. Jude Medical, LLC 2019-09-24 |
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