Pacific™ Plus

GUDID 08033477044026

Cath PCP035150130 PlusUS 03.5L150UL1300

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 08033477044026
• NIH Device Record Key: bdbd6c71-2f3d-4469-bca7-53e380b10f66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pacific™ Plus
• Version Model Number: PCP035150130
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 150 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. 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. Keep away from sunlight. Do not expose to organic solvents (such as alcohol), ionizing radiation or ultraviolet light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033477044026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123358

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: 5
• Public Version Date: 2019-10-21
• Device Publish Date: 2016-04-21

On-Brand Devices [Pacific™ Plus]

• 08033477080987: CATH PCP060120180 PLUS US 06L120UL1800
• 08033477080970: CATH PCP060120130 PLUS US 06L120UL1300
• 08033477080963: CATH PCP060120090 PLUS US 06L120UL0900
• 08033477080956: CATH PCP060080180 PLUS US 06L80UL1800
• 08033477080949: CATH PCP060080130 PLUS US 06L80UL1300
• 08033477080932: CATH PCP060080090 PLUS US 06L80UL0900
• 08033477080925: CATH PCP060060180 PLUS US 06L60UL1800
• 08033477080918: CATH PCP060060130 PLUS US 06L60UL1300
• 08033477080901: CATH PCP060060090 PLUS US 06L60UL0900
• 08033477080895: CATH PCP060040180 PLUS US 06L40UL1800
• 08033477080888: CATH PCP060040130 PLUS US 06L40UL1300
• 08033477080871: CATH PCP060040090 PLUS US 06L40UL0900
• 08033477080864: CATH PCP060020180 PLUS US 06L20UL1800
• 08033477080857: CATH PCP060020130 PLUS US 06L20UL1300
• 08033477080840: CATH PCP060020090 PLUS US 06L20UL0900
• 08033477080833: CATH PCP050120180 PLUS US 05L120UL1800
• 08033477080826: CATH PCP050120130 PLUS US 05L120UL1300
• 08033477080819: CATH PCP050120090 PLUS US 05L120UL0900
• 08033477080802: CATH PCP050080180 PLUS US 05L80UL1800
• 08033477080796: CATH PCP050080130 PLUS US 05L80UL1300
• 08033477080789: CATH PCP050080090 PLUS US 05L80UL0900
• 08033477080772: CATH PCP050060180 PLUS US 05L60UL1800
• 08033477080765: CATH PCP050060130 PLUS US 05L60UL1300
• 08033477080758: CATH PCP050060090 PLUS US 05L60UL0900
• 08033477080741: CATH PCP050040180 PLUS US 05L40UL1800
• 08033477080734: CATH PCP050040130 PLUS US 05L40UL1300
• 08033477080727: CATH PCP050040090 PLUS US 05L40UL0900
• 08033477080710: CATH PCP050020180 PLUS US 05L20UL1800
• 08033477080703: CATH PCP050020130 PLUS US 05L20UL1300
• 08033477080697: CATH PCP050020090 PLUS US 05L20UL0900
• 08033477080680: CATH PCP040120180 PLUS US 04L120UL1800
• 08033477080673: CATH PCP040120130 PLUS US 04L120UL1300
• 08033477080666: CATH PCP040120090 PLUS US 04L120UL0900
• 08033477080659: CATH PCP040080180 PLUS US 04L80UL1800
• 08033477080642: CATH PCP040080130 PLUS US 04L80UL1300
• 08033477080635: CATH PCP040080090 PLUS US 04L80UL0900
• 08033477080628: CATH PCP040060180 PLUS US 04L60UL1800
• 08033477080611: CATH PCP040060130 PLUS US 04L60UL1300
• 08033477080604: CATH PCP040060090 PLUS US 04L60UL0900
• 08033477080598: CATH PCP040040180 PLUS US 04L40UL1800
• 08033477080581: CATH PCP040040130 PLUS US 04L40UL1300
• 08033477080574: CATH PCP040040090 PLUS US 04L40UL0900
• 08033477080567: CATH PCP040020180 PLUS US 04L20UL1800
• 08033477080550: CATH PCP040020130 PLUS US 04L20UL1300
• 08033477080543: CATH PCP040020090 PLUS US 04L20UL0900
• 08033477080512: CATH PCP020150180 PLUS US 02L150UL1800
• 08033477080505: CATH PCP020150130 PLUS US 02L150UL1300
• 08033477080499: CATH PCP020150090 PLUS US 02L150UL0900
• 08033477080482: CATH PCP020120180 PLUS US 02L120UL1800
• 08033477080475: CATH PCP020120130 PLUS US 02L120UL1300