Admiral™ Xtreme

GUDID 08033477064956

CATH ADM120020130 ADM US 12.00L20 UL1300

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 08033477064956
• NIH Device Record Key: e8100b1c-f6de-49f0-9e57-7d0342845f2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admiral™ Xtreme
• Version Model Number: ADM120020130
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 12 Millimeter
• Length: 20 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as 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 (such as alcohol), ionizing radiation, or ultraviolet light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033477064956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173515

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: 3
• Public Version Date: 2020-07-20
• Device Publish Date: 2018-09-06

On-Brand Devices [Admiral™ Xtreme]

• 08033477066806: CATH ADM030020080 ADM US 03.00L20 UL0800
• 08033477066790: CATH ADM030040080 ADM US 03.00L40 UL0800
• 08033477066783: CATH ADM030080080 ADM US 03.00L80 UL0800
• 08033477066776: CATH ADM030100080 ADM US 03.00L100UL0800
• 08033477066769: CATH ADM030120080 ADM US 03.00L120UL0800
• 08033477066752: CATH ADM030020130 ADM US 03.00L20 UL1300
• 08033477066745: CATH ADM030040130 ADM US 03.00L40 UL1300
• 08033477066738: CATH ADM030080130 ADM US 03.00L80 UL1300
• 08033477066721: CATH ADM030100130 ADM US 03.00L100UL1300
• 08033477066714: CATH ADM030120130 ADM US 03.00L120UL1300
• 08033477066707: CATH ADM040020080 ADM US 04.00L20 UL0800
• 08033477066691: CATH ADM040040080 ADM US 04.00L40 UL0800
• 08033477066684: CATH ADM040060080 ADM US 04.00L60 UL0800
• 08033477066677: CATH ADM040080080 ADM US 04.00L80 UL0800
• 08033477066660: CATH ADM040100080 ADM US 04.00L100UL0800
• 08033477066653: CATH ADM040120080 ADM US 04.00L120UL0800
• 08033477066646: CATH ADM040150080 ADM US 04.00L150UL0800
• 08033477066639: CATH ADM040200080 ADM US 04.00L200UL0800
• 08033477066622: CATH ADM040250080 ADM US 04.00L250UL0800
• 08033477066615: CATH ADM040300080 ADM US 04.00L300UL0800
• 08033477066608: CATH ADM040020130 ADM US 04.00L20 UL1300
• 08033477066592: CATH ADM040040130 ADM US 04.00L40 UL1300
• 08033477066585: CATH ADM040060130 ADM US 04.00L60 UL1300
• 08033477066578: CATH ADM040080130 ADM US 04.00L80 UL1300
• 08033477066561: CATH ADM040100130 ADM US 04.00L100UL1300
• 08033477066554: CATH ADM040120130 ADM US 04.00L120UL1300
• 08033477066547: CATH ADM040150130 ADM US 04.00L150UL1300
• 08033477066530: CATH ADM040200130 ADM US 04.00L200UL1300
• 08033477066523: CATH ADM040250130 ADM US 04.00L250UL1300
• 08033477066516: CATH ADM040300130 ADM US 04.00L300UL1300
• 08033477066509: CATH ADM040020150 ADM US 04.00L020UL1500
• 08033477066493: CATH ADM040040150 ADM US 04.00L040UL1500
• 08033477066486: CATH ADM040060150 ADM US 04.00L060UL1500
• 08033477066479: CATH ADM040080150 ADM US 04.00L080UL1500
• 08033477066462: CATH ADM040100150 ADM US 04.00L100UL1500
• 08033477066455: CATH ADM040120150 ADM US 04.00L120UL1500
• 08033477066448: CATH ADM040150150 ADM US 04.00L150UL1500
• 08033477066431: CATH ADM040200150 ADM US 04.00L200UL1500
• 08033477066424: CATH ADM050020080 ADM US 05.00L20 UL0800
• 08033477066417: CATH ADM050040080 ADM US 05.00L40 UL0800
• 08033477066400: CATH ADM050060080 ADM US 05.00L60 UL0800
• 08033477066394: CATH ADM050080080 ADM US 05.00L80 UL0800
• 08033477066387: CATH ADM050100080 ADM US 05.00L100UL0800
• 08033477066370: CATH ADM050120080 ADM US 05.00L120UL0800
• 08033477064963: CATH ADM120040130 ADM US 12.00L40 UL1300
• 08033477064956: CATH ADM120020130 ADM US 12.00L20 UL1300
• 08033477064949: CATH ADM120040080 ADM US 12.00L40 UL0800
• 08033477064932: CATH ADM120020080 ADM US 12.00L20 UL0800
• 08033477064925: CATH ADM100040130 ADM US 10.00L40 UL1300
• 08033477064918: CATH ADM100020130 ADM US 10.00L20 UL1300