IN.PACT™ Admiral™
GUDID 00643169383289
DEB ADM06012013P 06.00 L120 UL1300 US
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00643169383289 |
| NIH Device Record Key | 9ccdecd2-0b1f-443c-8fba-60c94248676a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IN.PACT™ Admiral™ |
| Version Model Number | ADM06012013P |
| 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 | true |
| 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 |
Customer Support Contacts
Device Dimensions
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in the original container. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169383289 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140010
FDA Product Code
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2015-01-29 |
On-Brand Devices [IN.PACT™ Admiral™]
| 00643169975088 | DCB ADM06025013P 06.00 L250 UL1300 US |
| 00643169975071 | DCB ADM05025013P 05.00 L250 UL1300 US |
| 00643169975064 | DCB ADM04025013P 04.00 L250 UL1300 US |
| 00643169975057 | DCB ADM06025008P 06.00 L250 UL0800 US |
| 00643169975040 | DCB ADM05025008P 05.00 L250 UL0800 US |
| 00643169975033 | DCB ADM04025008P 04.00 L250 UL0800 US |
| 00643169975026 | DCB ADM06020013P 06.00 L200 UL1300 US |
| 00643169975019 | DCB ADM05020013P 05.00 L200 UL1300 US |
| 00643169975002 | DCB ADM04020013P 04.00 L200 UL1300 US |
| 00643169974999 | DCB ADM06020008P 06.00 L200 UL0800 US |
| 00643169974982 | DCB ADM05020008P 05.00 L200 UL0800 US |
| 00643169974975 | DCB ADM04020008P 04.00 L200 UL0800 US |
| 00643169859975 | DEB ADM06012013P 06.00 L120 UL1300 US |
| 00643169859968 | DEB ADM06012008P 06.00 L120 UL800 US |
| 00643169576353 | DEB ADM06015013P 06.00 L150 UL1300 US |
| 00643169576346 | DEB ADM06015008P 06.00 L150 UL0800 US |
| 00643169576339 | DEB ADM05015013P 05.00 L150 UL1300 US |
| 00643169576322 | DEB ADM05015008P 05.00 L150 UL0800 US |
| 00643169576315 | DEB ADM04015013P 04.00 L150 UL1300 US |
| 00643169576308 | DEB ADM04015008P 04.00 L150 UL0800 US |
| 00643169383654 | DEB ADM06004008P 06.00 L040 UL0800 US |
| 00643169383630 | DEB ADM05012013P 05.00 L120 UL1300 US |
| 00643169383623 | DEB ADM05008013P 05.00 L080 UL1300 US |
| 00643169383616 | DEB ADM05006013P 05.00 L060 UL1300 US |
| 00643169383609 | DEB ADM05004013P 05.00 L040 UL1300 US |
| 00643169383586 | DEB ADM05012008P 05.00 L120 UL0800 US |
| 00643169383579 | DEB ADM05008008P 05.00 L080 UL0800 US |
| 00643169383562 | DEB ADM05006008P 05.00 L060 UL0800 US |
| 00643169383555 | DEB ADM05004008P 05.00 L040 UL0800 US |
| 00643169383531 | DEB ADM04012013P 04.00 L120 UL1300 US |
| 00643169383524 | DEB ADM04008013P 04.00 L080 UL1300 US |
| 00643169383517 | DEB ADM04006013P 04.00 L060 UL1300 US |
| 00643169383500 | DEB ADM04004013P 04.00 L040 UL1300 US |
| 00643169383487 | DEB ADM04012008P 04.00 L120 UL0800 US |
| 00643169383470 | DEB ADM04008008P 04.00 L080 UL0800 US |
| 00643169383463 | DEB ADM04006008P 04.00 L060 UL0800 US |
| 00643169383456 | DEB ADM04004008P 04.00 L040 UL0800 US |
| 00643169383364 | DEB ADM07008013P 07.00 L080 UL1300 US |
| 00643169383357 | DEB ADM07006013P 07.00 L060 UL1300 US |
| 00643169383340 | DEB ADM07004013P 07.00 L040 UL1300 US |
| 00643169383326 | DEB ADM07008008P 07.00 L080 UL0800 US |
| 00643169383319 | DEB ADM07006008P 07.00 L060 UL0800 US |
| 00643169383302 | DEB ADM07004008P 07.00 L040 UL0800 US |
| 00643169383289 | DEB ADM06012013P 06.00 L120 UL1300 US |
| 00643169383272 | DEB ADM06008013P 06.00 L080 UL1300 US |
| 00643169383265 | DEB ADM06006013P 06.00 L060 UL1300 US |
| 00643169383258 | DEB ADM06004013P 06.00 L040 UL1300 US |
| 00643169383234 | DEB ADM06008008P 06.00 L080 UL0800 US |
| 00643169383227 | DEB ADM06006008P 06.00 L060 UL0800 US |
Trademark Results [IN.PACT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IN.PACT 79320694 not registered Live/Pending |
INVATEC Technology Center GmbH 2021-08-10 |
 IN.PACT 79074790 3864435 Dead/Cancelled |
INVATEC Technology Center GmbH 2009-06-19 |
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