Fortrex™

GUDID 00763000106225

PTA A35HPV08080080 FORTREX V02

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00763000106225
• NIH Device Record Key: cb8df95d-464d-44d5-b196-d5bab0d2d2e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortrex™
• Version Model Number: A35HPV08080080
• 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

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter away from sunlight at room temperature in a dry 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 *Store the catheter away from sunlight at room temperature in a dry 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 *Store the catheter away from sunlight at room temperature in a dry 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 *Store the catheter away from sunlight at room temperature in a dry 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 *Store the catheter away from sunlight at room temperature in a dry 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 *Store the catheter away from sunlight at room temperature in a dry 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	00763000106225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142654

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: 2018-09-18

On-Brand Devices [Fortrex™]

• 00763000106447: PTA A35HPV12080135 FORTREX V02
• 00763000106430: PTA A35HPV12080080 FORTREX V02
• 00763000106423: PTA A35HPV12080040 FORTREX V02
• 00763000106416: PTA A35HPV12040135 FORTREX V02
• 00763000106409: PTA A35HPV12040080 FORTREX V02
• 00763000106393: PTA A35HPV12040040 FORTREX V02
• 00763000106386: PTA A35HPV10080135 FORTREX V02
• 00763000106379: PTA A35HPV10080080 FORTREX V02
• 00763000106362: PTA A35HPV10080040 FORTREX V02
• 00763000106355: PTA A35HPV10040135 FORTREX V02
• 00763000106348: PTA A35HPV10040080 FORTREX V02
• 00763000106331: PTA A35HPV10040040 FORTREX V02
• 00763000106324: PTA A35HPV09080135 FORTREX V02
• 00763000106317: PTA A35HPV09080080 FORTREX V02
• 00763000106300: PTA A35HPV09080040 FORTREX V02
• 00763000106294: PTA A35HPV09040135 FORTREX V02
• 00763000106287: PTA A35HPV09040080 FORTREX V02
• 00763000106270: PTA A35HPV09040040 FORTREX V02
• 00763000106263: PTA A35HPV08100135 FORTREX V02
• 00763000106256: PTA A35HPV08100080 FORTREX V02
• 00763000106249: PTA A35HPV08100040 FORTREX V02
• 00763000106232: PTA A35HPV08080135 FORTREX V02
• 00763000106225: PTA A35HPV08080080 FORTREX V02
• 00763000106218: PTA A35HPV08080040 FORTREX V02
• 00763000106201: PTA A35HPV08040135 FORTREX V02
• 00763000106195: PTA A35HPV08040080 FORTREX V02
• 00763000106188: PTA A35HPV08040040 FORTREX V02
• 00763000106171: PTA A35HPV07100135 FORTREX V02
• 00763000106164: PTA A35HPV07100080 FORTREX V02
• 00763000106157: PTA A35HPV07100040 FORTREX V02
• 00763000106140: PTA A35HPV07080135 FORTREX V02
• 00763000106133: PTA A35HPV07080080 FORTREX V02
• 00763000106126: PTA A35HPV07080040 FORTREX V02
• 00763000106119: PTA A35HPV07040135 FORTREX V02
• 00763000106102: PTA A35HPV07040080 FORTREX V02
• 00763000106096: PTA A35HPV07040040 FORTREX V02
• 00763000106089: PTA A35HPV07020135 FORTREX V02
• 00763000106072: PTA A35HPV07020080 FORTREX V02
• 00763000106065: PTA A35HPV07020040 FORTREX V02
• 00763000106058: PTA A35HPV06100135 FORTREX V02
• 00763000106041: PTA A35HPV06100080 FORTREX V02
• 00763000106034: PTA A35HPV06100040 FORTREX V02
• 00763000106027: PTA A35HPV06080135 FORTREX V02
• 00763000106010: PTA A35HPV06080080 FORTREX V02
• 00763000106003: PTA A35HPV06080040 FORTREX V02
• 00763000105990: PTA A35HPV06040135 FORTREX V02
• 00763000105983: PTA A35HPV06040080 FORTREX V02
• 00763000105976: PTA A35HPV06040040 FORTREX V02
• 00763000105969: PTA A35HPV06020135 FORTREX V02
• 00763000105952: PTA A35HPV06020080 FORTREX V02