Chocolate®

GUDID 00763000240356

PTA CB1415025040 CHOCOLATE 014 V02

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000240356
• NIH Device Record Key: 60ad9bd5-c710-409e-a15f-10e0a61d44f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate®
• Version Model Number: CB1415025040OTW
• 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

Device Dimensions

• Balloon Length: 40 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000240356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130414

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: 2019-10-28
• Device Publish Date: 2019-10-20

On-Brand Devices [Chocolate®]

• 00763000240462: PTA CB1812060120 CHOCOLATE 018 V02
• 00763000240455: PTA CB1812060080 CHOCOLATE 018 V02
• 00763000240448: PTA CB1812060040 CHOCOLATE 018 V02
• 00763000240431: PTA CB1812050120 CHOCOLATE 018 V02
• 00763000240424: PTA CB1812050080 CHOCOLATE 018 V02
• 00763000240417: PTA CB1812050040 CHOCOLATE 018 V02
• 00763000240400: PTA CB1415030120 CHOCOLATE 014 V02
• 00763000240394: PTA CB1415030080 CHOCOLATE 014 V02
• 00763000240387: PTA CB1415030040 CHOCOLATE 014 V02
• 00763000240370: PTA CB1415025120 CHOCOLATE 014 V02
• 00763000240363: PTA CB1415025080 CHOCOLATE 014 V02
• 00763000240356: PTA CB1415025040 CHOCOLATE 014 V02
• 00763000240349: PTA CB1413540120 CHOCOLATE 014 V02
• 00763000240332: PTA CB1413540080 CHOCOLATE 014 V02
• 00763000240325: PTA CB1413540040 CHOCOLATE 014 V02
• 00763000240318: PTA CB1413535120 CHOCOLATE 014 V02
• 00763000240301: PTA CB1413535080 CHOCOLATE 014 V02
• 00763000240295: PTA CB1413535040 CHOCOLATE 014 V02