| Primary Device ID | 00763000181208 |
| NIH Device Record Key | fc62d82b-376e-4fd9-9aa3-e0358efbde68 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5832S |
| Company DUNS | 006261481 |
| 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 | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Length | 1.83 Meter |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000181208 [Primary] |
| LWP | Implantable pulse generator, pacemaker (non-CRT) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00763000181208]
Ethylene Oxide;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-31 |
| Device Publish Date | 2021-05-22 |
| 20763000980096 - NA | 2025-08-25 IMPEDANCE PATCH AFR-00015 |
| 20763000980119 - NA | 2025-08-25 MAGNETIC PATCH AFR-00021 |
| 00199150039371 - NA | 2025-08-22 CUSTOM PACK BB11U72R1 P/T |
| 00199150040872 - NA | 2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG |
| 00199150041145 - NA | 2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH |
| 00199150041978 - NA | 2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY |
| 00199150041299 - NA | 2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E |
| 20199150041118 - NA | 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE |