| Primary Device ID | 00763000181321 |
| NIH Device Record Key | 3be5893e-94c6-4ea9-9097-4b7b496f551a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 2090EC |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000181321 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
[00763000181321]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-21 |
| Device Publish Date | 2021-06-12 |
| 20199150045680 - NA | 2025-09-22 CUSTOM PACK BB12R79R 10PK EVL COA 3/8 TU |
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| 00199150045815 - NA | 2025-09-22 CUSTOM PACK BB10B09R2 EVL EC SUP PK |
| 00199150045822 - NA | 2025-09-22 CUSTOM PACK BB2S09R29 CV PACK |
| 00199150045839 - NA | 2025-09-22 CUSTOM PACK BB12J21R6 EVL ADULT EC |
| 00199150045860 - NA | 2025-09-22 CUSTOM PACK BB10B53R7 ADULT SUPPORT |
| 00199150046010 - NA | 2025-09-22 CUSTOM PACK BB5G56R17 PUMP TBL |