| Primary Device ID | 00613994524232 |
| NIH Device Record Key | 65c64223-e360-442e-96ea-4211f50946cc |
| Commercial Distribution Discontinuation | 2019-01-25 |
| Commercial Distribution Status | Not 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 |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994524232 [Primary] |
| OSR | Pacemaker/icd/crt non-implanted components |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994524232]
Ethylene Oxide
[00613994524232]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2014-09-23 |
| 00199150001811 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU04020013P D4.0 L200 UL0130 |
| 00199150001828 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU04020020P D4.0 L200 UL0200 |
| 00199150001842 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU04025013P D4.0 L250 UL0130 |
| 00199150001859 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU04025020P D4.0 L250 UL0200 |
| 00199150001873 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU05020013P D5.0 L200 UL0130 |
| 00199150001880 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU05020020P D5.0 L200 UL0200 |
| 00199150001903 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU05025013P D5.0 L250 UL0130 |
| 00199150001910 - IN.PACT™ 018 | 2026-03-27 DCB 018XL IPU05025020P D5.0 L250 UL0200 |