PACIFIC XTREME

GUDID 08033477058344

CATH PCU070250130 PCU US 07 00L250UL1300

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 08033477058344
• NIH Device Record Key: 9899f14c-a93f-4627-accd-494d35e21be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACIFIC XTREME
• Version Model Number: PCU070250130
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	08033477058344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103464

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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: 2017-05-22

On-Brand Devices [PACIFIC XTREME]

• 08033477076102: CATH PCU050300130 PCU US 05 00L300UL1300
• 08033477076096: CATH PCU050300090 PCU US 05 00L300UL0900
• 08033477076089: CATH PCU050250130 PCU US 05 00L250UL1300
• 08033477076072: CATH PCU050250090 PCU US 05 00L250UL0900
• 08033477076065: CATH PCU050200130 PCU US 05 00L200UL1300
• 08033477076058: CATH PCU050200090 PCU US 05 00L200UL0900
• 08033477076041: CATH PCU050150130 PCU US 05 00L150UL1300
• 08033477076034: CATH PCU050150090 PCU US 05 00L150UL0900
• 08033477076027: CATH PCU040300130 PCU US 04 00L300UL1300
• 08033477076010: CATH PCU040300090 PCU US 04 00L300UL0900
• 08033477076003: CATH PCU040250130 PCU US 04 00L250UL1300
• 08033477075990: CATH PCU040250090 PCU US 04 00L250UL0900
• 08033477075983: CATH PCU040200130 PCU US 04 00L200UL1300
• 08033477075976: CATH PCU040200090 PCU US 04 00L200UL0900
• 08033477075969: CATH PCU040150130 PCU US 04 00L150UL1300
• 08033477075952: CATH PCU070250130 PCU US 07 00L250UL1300
• 08033477075945: CATH PCU070250090 PCU US 07 00L250UL0900
• 08033477075938: CATH PCU070200130 PCU US 07 00L200UL1300
• 08033477075921: CATH PCU070200090 PCU US 07 00L200UL0900
• 08033477075914: CATH PCU070150130 PCU US 07 00L150UL1300
• 08033477075907: CATH PCU070150090 PCU US 07 00L150UL0900
• 08033477075891: CATH PCU060300130 PCU US 06 00L300UL1300
• 08033477075884: CATH PCU060300090 PCU US 06 00L300UL0900
• 08033477075877: CATH PCU060250130 PCU US 06 00L250UL1300
• 08033477075860: CATH PCU060250090 PCU US 06 00L250UL0900
• 08033477075853: CATH PCU060200130 PCU US 06 00L200UL1300
• 08033477075846: CATH PCU060200090 PCU US 06 00L200UL0900
• 08033477075839: CATH PCU060150130 PCU US 06 00L150UL1300
• 08033477075594: CATH PCU060150090 PCU US 06 00L150UL0900
• 08033477075587: CATH PCU040150090 PCU US 04 00L150UL0900
• 08033477058504: CATH PCU050300130 PCU US 05 00L300UL1300
• 08033477058498: CATH PCU050300090 PCU US 05 00L300UL0900
• 08033477058481: CATH PCU050250130 PCU US 05 00L250UL1300
• 08033477058474: CATH PCU050250090 PCU US 05 00L250UL0900
• 08033477058467: CATH PCU050200130 PCU US 05 00L200UL1300
• 08033477058450: CATH PCU050200090 PCU US 05 00L200UL0900
• 08033477058443: CATH PCU050150130 PCU US 05 00L150UL1300
• 08033477058436: CATH PCU050150090 PCU US 05 00L150UL0900
• 08033477058429: CATH PCU040300130 PCU US 04 00L300UL1300
• 08033477058412: CATH PCU040300090 PCU US 04 00L300UL0900
• 08033477058405: CATH PCU040250130 PCU US 04 00L250UL1300
• 08033477058399: CATH PCU040250090 PCU US 04 00L250UL0900
• 08033477058382: CATH PCU040200130 PCU US 04 00L200UL1300
• 08033477058375: CATH PCU040200090 PCU US 04 00L200UL0900
• 08033477058368: CATH PCU040150130 PCU US 04 00L150UL1300
• 08033477058351: CATH PCU040150090 PCU US 04 00L150UL0900
• 08033477058344: CATH PCU070250130 PCU US 07 00L250UL1300
• 08033477058337: CATH PCU070250090 PCU US 07 00L250UL0900
• 08033477058320: CATH PCU070200130 PCU US 07 00L200UL1300
• 08033477058313: CATH PCU070200090 PCU US 07 00L200UL0900