| Primary Device ID | 20763000725598 |
| NIH Device Record Key | 8634b378-253b-49d4-999a-558135bdec2e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6214-S5 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000725594 [Primary] |
| GS1 | 20763000725598 [Package] Contains: 00763000725594 Package: PK [5 Units] In Commercial Distribution |
| DYB | Introducer, catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-26 |
| Device Publish Date | 2024-11-18 |
| 00763000004101 - NA | 2025-09-02 COMMUNICATOR TM90T0 TDD PROX |
| 00199150042050 - NA | 2025-09-01 CUSTOM PACK SSHY12R43R HLN BB8G55R1 |
| 00199150042104 - NA | 2025-09-01 CUSTOM PACK BB12R13R1 HLN SUTT PED |
| 00199150042111 - NA | 2025-09-01 CUSTOM PACK BB12Q88R1 HLN INF SUTTE |
| 00763000998271 - Affera™ Integrated Mapping System | 2025-09-01 MAP SYS AFR-00016 IMPEDANCE US PLX |
| 00199150042005 - NA | 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8 |
| 00199150042012 - NA | 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM |
| 00199150042029 - NA | 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4 |