ADMIRAL XTREME
GUDID 08033477057415
CATH ADM070250080 ADM US 07 00L250UL0800
MEDTRONIC, INC.
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 08033477057415 |
| NIH Device Record Key | e04f339a-7e86-4618-81d7-44568663c5e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADMIRAL XTREME |
| Version Model Number | ADM070250080 |
| 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 | 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
| 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 |
Device Dimensions
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
| Outer Diameter | 7 Millimeter |
| Length | 250 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at controlled room temperature in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033477057415 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100921
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
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 | 2020-07-20 |
| Device Publish Date | 2016-07-01 |
On-Brand Devices [ADMIRAL XTREME]
| 08033477058207 | CATH ADM090040130 ADM US 09 00L40 UL1300 |
| 08033477058191 | CATH ADM090040080 ADM US 09 00L40 UL0800 |
| 08033477058184 | CATH ADM090020130 ADM US 09 00L20 UL1300 |
| 08033477058177 | CATH ADM090020080 ADM US 09 00L20 UL0800 |
| 08033477058160 | CATH ADM080040130 ADM US 08 00L40 UL1300 |
| 08033477058153 | CATH ADM080040080 ADM US 08 00L40 UL0800 |
| 08033477058146 | CATH ADM080020130 ADM US 08 00L20 UL1300 |
| 08033477058139 | CATH ADM080020080 ADM US 08 00L20 UL0800 |
| 08033477058122 | CATH ADM070080130 ADM US 07 00L80 UL1300 |
| 08033477058115 | CATH ADM070080080 ADM US 07 00L80 UL0800 |
| 08033477058108 | CATH ADM070060130 ADM US 07 00L60 UL1300 |
| 08033477058092 | CATH ADM070060080 ADM US 07 00L60 UL0800 |
| 08033477058085 | CATH ADM070040130 ADM US 07 00L40 UL1300 |
| 08033477058078 | CATH ADM070040080 ADM US 07 00L40 UL0800 |
| 08033477058061 | CATH ADM070020130 ADM US 07 00L20 UL1300 |
| 08033477058054 | CATH ADM070020080 ADM US 07 00L20 UL0800 |
| 08033477058047 | CATH ADM060120130 ADM US 06 00L120UL1300 |
| 08033477058030 | CATH ADM060120080 ADM US 06 00L120UL0800 |
| 08033477058023 | CATH ADM060080130 ADM US 06 00L80 UL1300 |
| 08033477058016 | CATH ADM060080080 ADM US 06 00L80 UL0800 |
| 08033477058009 | CATH ADM060060130 ADM US 06 00L60 UL1300 |
| 08033477057996 | CATH ADM060060080 ADM US 06 00L60 UL0800 |
| 08033477057989 | CATH ADM060040130 ADM US 06 00L40 UL1300 |
| 08033477057972 | CATH ADM060040080 ADM US 06 00L40 UL0800 |
| 08033477057965 | CATH ADM060020130 ADM US 06 00L20 UL1300 |
| 08033477057958 | CATH ADM060020080 ADM US 06 00L20 UL0800 |
| 08033477057941 | CATH ADM050120130 ADM US 05 00L120UL1300 |
| 08033477057934 | CATH ADM050120080 ADM US 05 00L120UL0800 |
| 08033477057927 | CATH ADM050080130 ADM US 05 00L80 UL1300 |
| 08033477057910 | CATH ADM050080080 ADM US 05 00L80 UL0800 |
| 08033477057903 | CATH ADM050060130 ADM US 05 00L60 UL1300 |
| 08033477057897 | CATH ADM050060080 ADM US 05 00L60 UL0800 |
| 08033477057880 | CATH ADM050040130 ADM US 05 00L40 UL1300 |
| 08033477057873 | CATH ADM050040080 ADM US 05 00L40 UL0800 |
| 08033477057866 | CATH ADM050020130 ADM US 05 00L20 UL1300 |
| 08033477057859 | CATH ADM050020080 ADM US 05 00L20 UL0800 |
| 08033477057842 | CATH ADM040120130 ADM US 04 00L120UL1300 |
| 08033477057835 | CATH ADM040120080 ADM US 04 00L120UL0800 |
| 08033477057828 | CATH ADM040080130 ADM US 04 00L80 UL1300 |
| 08033477057811 | CATH ADM040080080 ADM US 04 00L80 UL0800 |
| 08033477057804 | CATH ADM040060130 ADM US 04 00L60 UL1300 |
| 08033477057798 | CATH ADM040060080 ADM US 04 00L60 UL0800 |
| 08033477057781 | CATH ADM040040130 ADM US 04 00L40 UL1300 |
| 08033477057774 | CATH ADM040040080 ADM US 04 00L40 UL0800 |
| 08033477057767 | CATH ADM040020130 ADM US 04 00L20 UL1300 |
| 08033477057750 | CATH ADM040020080 ADM US 04 00L20 UL0800 |
| 08033477057743 | CATH ADM030120130 ADM US 03 00L120UL1300 |
| 08033477057736 | CATH ADM030120080 ADM US 03 00L120UL0800 |
| 08033477057729 | CATH ADM030080130 ADM US 03 00L80 UL1300 |
| 08033477057712 | CATH ADM030080080 ADM US 03 00L80 UL0800 |
Trademark Results [ADMIRAL XTREME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADMIRAL XTREME 79024620 not registered Dead/Abandoned |
INVATEC S.P.A. 2006-04-06 |
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