Access® Therapy
GUDID 00613994397836
PROG 7436 KINETRA EZ PATNT ROHs US MKT
MEDTRONIC, INC.
Active-implantable-device communicator| Primary Device ID | 00613994397836 |
| NIH Device Record Key | edbc68d1-7f74-4937-a256-d03eff8b411f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Access® Therapy |
| Version Model Number | 7436 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, 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 | false |
| 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
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994397836 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- H050003
FDA Product Code
| MFR | Stimulator, brain, implanted, for behavior modification |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000747459 - NA | 2026-02-17 CATHETER C320LBBL45 LARGE CURVE 45 GBL |
| 00763000747466 - NA | 2026-02-17 CATHETER C320LBBL48 LARGE CURVE 48 GBL |
| 00763000747473 - NA | 2026-02-17 CATHETER C320LBBS45 SMALL CURVE 45 GBL |
| 00763000747480 - NA | 2026-02-17 CATHETER C320LBBS48 SMALL CURVE 48 GBL |
| 00199150006045 - N/A | 2026-02-10 COMM HANDSET KIT TH90D01 DBS EMANUAL US |
| 00199150068302 - NA | 2026-02-10 CUSTOM PACK BB12M12R7 HLO CPB |
| 20199150068351 - NA | 2026-02-10 CUSTOM PACK 12C75R1 20PK ACC BIDMC-PCK |
| 20199150068382 - NA | 2026-02-10 CUSTOM PACK BB12C41R9 10PK ACC LNG PK |
Trademark Results [Access]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCESS 98849021 not registered Live/Pending |
Access Members, Inc. 2024-11-12 |
 ACCESS 98604507 not registered Live/Pending |
Better Earth LLC 2024-06-17 |
 ACCESS 98301775 not registered Live/Pending |
Access Group, Inc. 2023-12-06 |
 ACCESS 98289355 not registered Live/Pending |
Penumbra, Inc. 2023-11-28 |
 ACCESS 98182378 not registered Live/Pending |
Troy and Sabina Benavides 2023-09-15 |
 ACCESS 98017184 not registered Live/Pending |
Sony Interactive Entertainment Inc. 2023-05-28 |
 ACCESS 97936930 not registered Live/Pending |
Winnebago Industries, Inc. 2023-05-15 |
 ACCESS 97792738 not registered Live/Pending |
Piv Train Inc 2023-02-13 |
 ACCESS 97756255 not registered Live/Pending |
Coppel S.A. de C.V. 2023-01-16 |
 ACCESS 97202119 not registered Live/Pending |
Access Alternative Investments, Inc. 2022-01-04 |
 ACCESS 97180047 not registered Live/Pending |
Wicket, LLC 2021-12-20 |
 ACCESS 90827919 not registered Live/Pending |
Access Eforms, LP 2021-07-14 |
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