RapidCross™

GUDID 00763000111182

PTA A14BX035210090 RAPIDCROSS V04

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000111182
• NIH Device Record Key: d80c5208-c118-433d-9413-7dd4af1c40b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RapidCross™
• Version Model Number: A14BX035210090
• Company DUNS: 968903703
• Company Name: Covidien LP
• 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

Device Dimensions

• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter
• Length: 210 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The RapidCross catheter should be stored in a cool, dry, and dark place. 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. 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 *The RapidCross catheter should be stored in a cool, dry, and dark place. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000111182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130911

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: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-12-30

On-Brand Devices [RapidCross™]

• 00763000111359: PTA A14BX040210170 RAPIDCROSS V04
• 00763000111342: PTA A14BX040210090 RAPIDCROSS V04
• 00763000111335: PTA A14BX040150170 RAPIDCROSS V04
• 00763000111328: PTA A14BX040150090 RAPIDCROSS V04
• 00763000111311: PTA A14BX040120170 RAPIDCROSS V04
• 00763000111304: PTA A14BX040120090 RAPIDCROSS V04
• 00763000111298: PTA A14BX040100170 RAPIDCROSS V04
• 00763000111281: PTA A14BX040100090 RAPIDCROSS V04
• 00763000111274: PTA A14BX040080170 RAPIDCROSS V04
• 00763000111267: PTA A14BX040080090 RAPIDCROSS V04
• 00763000111250: PTA A14BX040060170 RAPIDCROSS V04
• 00763000111243: PTA A14BX040060090 RAPIDCROSS V04
• 00763000111236: PTA A14BX040040170 RAPIDCROSS V04
• 00763000111229: PTA A14BX040040090 RAPIDCROSS V04
• 00763000111212: PTA A14BX040020170 RAPIDCROSS V04
• 00763000111205: PTA A14BX040020090 RAPIDCROSS V04
• 00763000111199: PTA A14BX035210170 RAPIDCROSS V04
• 00763000111182: PTA A14BX035210090 RAPIDCROSS V04
• 00763000111175: PTA A14BX035150170 RAPIDCROSS V04
• 00763000111168: PTA A14BX035150090 RAPIDCROSS V04
• 00763000111151: PTA A14BX035120170 RAPIDCROSS V04
• 00763000111144: PTA A14BX035120090 RAPIDCROSS V04
• 00763000111137: PTA A14BX035100170 RAPIDCROSS V04
• 00763000111120: PTA A14BX035100090 RAPIDCROSS V04
• 00763000111113: PTA A14BX035080170 RAPIDCROSS V04
• 00763000111106: PTA A14BX035080090 RAPIDCROSS V04
• 00763000111090: PTA A14BX035060170 RAPIDCROSS V04
• 00763000111083: PTA A14BX035060090 RAPIDCROSS V04
• 00763000111076: PTA A14BX035040170 RAPIDCROSS V04
• 00763000111069: PTA A14BX035040090 RAPIDCROSS V04
• 00763000111052: PTA A14BX035020170 RAPIDCROSS V04
• 00763000111045: PTA A14BX035020090 RAPIDCROSS V04
• 00763000111038: PTA A14BX030210170 RAPIDCROSS V04
• 00763000111021: PTA A14BX030210090 RAPIDCROSS V04
• 00763000111014: PTA A14BX030150170 RAPIDCROSS V04
• 00763000111007: PTA A14BX030150090 RAPIDCROSS V04
• 00763000110994: PTA A14BX030120170 RAPIDCROSS V04
• 00763000110987: PTA A14BX030120090 RAPIDCROSS V04
• 00763000110970: PTA A14BX030100170 RAPIDCROSS V04
• 00763000110963: PTA A14BX030100090 RAPIDCROSS V04
• 00763000110956: PTA A14BX030080170 RAPIDCROSS V04
• 00763000110949: PTA A14BX030080090 RAPIDCROSS V04
• 00763000110932: PTA A14BX030060170 RAPIDCROSS V04
• 00763000110925: PTA A14BX030060090 RAPIDCROSS V04
• 00763000110918: PTA A14BX030040170 RAPIDCROSS V04
• 00763000110901: PTA A14BX030040090 RAPIDCROSS V04
• 00763000110895: PTA A14BX030020170 RAPIDCROSS V04
• 00763000110888: PTA A14BX030020090 RAPIDCROSS V04
• 00763000110871: PTA A14BX025210170 RAPIDCROSS V04
• 00763000110864: PTA A14BX025210090 RAPIDCROSS V04