Chocolate™

GUDID 00763000500078

PTA CB1413535080 CHOCOLATE 014 V05

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000500078
• NIH Device Record Key: 3c22d82c-b654-41d7-be47-42e57b12b78b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate™
• Version Model Number: CB1413535080OTW
• 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
• 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

• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 80 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000500078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213631

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-17
• Device Publish Date: 2023-03-09

On-Brand Devices [Chocolate™]

• 00763000500238: PTA CB1812060120 CHOCOLATE 018 V05
• 00763000500221: PTA CB1812060080 CHOCOLATE 018 V05
• 00763000500214: PTA CB1812060040 CHOCOLATE 018 V05
• 00763000500207: PTA CB1812050120 CHOCOLATE 018 V05
• 00763000500191: PTA CB1812050080 CHOCOLATE 018 V05
• 00763000500184: PTA CB1812050040 CHOCOLATE 018 V05
• 00763000500177: PTA CB1415030120 CHOCOLATE 014 V05
• 00763000500160: PTA CB1415030080 CHOCOLATE 014 V05
• 00763000500153: PTA CB1415030040 CHOCOLATE 014 V05
• 00763000500146: PTA CB1415025120 CHOCOLATE 014 V05
• 00763000500139: PTA CB1415025080 CHOCOLATE 014 V05
• 00763000500122: PTA CB1415025040 CHOCOLATE 014 V05
• 00763000500115: PTA CB1413540120 CHOCOLATE 014 V05
• 00763000500108: PTA CB1413540080 CHOCOLATE 014 V05
• 00763000500092: PTA CB1413540040 CHOCOLATE 014 V05
• 00763000500085: PTA CB1413535120 CHOCOLATE 014 V05
• 00763000500078: PTA CB1413535080 CHOCOLATE 014 V05
• 00763000500061: PTA CB1413535040 CHOCOLATE 014 V05