Fortrex A35HPV05040040

GUDID 00821684057322

0.035 IN OTW PTA Balloon Catheter

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00821684057322
• NIH Device Record Key: a69ab7e1-8f84-47af-811b-b69c19d219ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortrex
• Version Model Number: A35HPV05040040
• Catalog Number: A35HPV05040040
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: true
• 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: true
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684057322 [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: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2015-10-09

On-Brand Devices [Fortrex]

• 00821684057919: 0.035 OTW PTA Balloon Catheter
• 00821684057902: 0.035 OTW PTA Balloon Catheter
• 00821684057896: 0.035 OTW PTA Balloon Catheter
• 00821684057889: 0.035 OTW PTA Balloon Catheter
• 00821684057872: 0.035 IN OTW PTA Balloon Catheter
• 00821684057865: 0.035 OTW PTA Balloon Catheter
• 00821684057858: 0.035 OTW PTA Balloon Catheter
• 00821684057841: 0.035 IN OTW PTA Balloon Catheter
• 00821684057834: 0.035 OTW PTA Balloon Catheter
• 00821684057827: 0.035 OTW PTA Balloon Catheter
• 00821684057810: 0.035 IN OTW PTA Balloon Catheter
• 00821684057803: 0.035 IN OTW PTA Balloon Catheter
• 00821684057797: 0.035 OTW PTA Balloon Catheter
• 00821684057780: 0.035 IN OTW PTA Balloon Catheter
• 00821684057773: 0.035 OTW PTA Balloon Catheter
• 00821684057766: 0.035 OTW PTA Balloon Catheter
• 00821684057759: 0.035 IN OTW PTA Balloon Catheter
• 00821684057742: 0.035 IN OTW PTA Balloon Catheter
• 00821684057735: 0.035 OTW PTA Balloon Catheter
• 00821684057728: 0.035 OTW PTA Balloon Catheter
• 00821684057711: 0.035 OTW PTA Balloon Catheter
• 00821684057704: 0.035 OTW PTA Balloon Catheter
• 00821684057698: 0.035 IN OTW PTA Balloon Catheter
• 00821684057681: 0.035 IN OTW PTA Balloon Catheter
• 00821684057674: 0.035 OTW PTA Balloon Catheter
• 00821684057667: 0.035 IN OTW PTA Balloon Catheter
• 00821684057650: 0.035 IN OTW PTA Balloon Catheter
• 00821684057643: 0.035 OTW PTA Balloon Catheter
• 00821684057636: 0.035 IN OTW PTA Balloon Catheter
• 00821684057629: 0.035 OTW PTA Balloon Catheter
• 00821684057612: 0.035 OTW PTA Balloon Catheter
• 00821684057605: 0.035 IN OTW PTA Balloon Catheter
• 00821684057599: 0.035 OTW PTA Balloon Catheter
• 00821684057582: 0.035 OTW PTA Balloon Catheter
• 00821684057575: 0.035 IN OTW PTA Balloon Catheter
• 00821684057568: 0.035 IN OTW PTA Balloon Catheter
• 00821684057551: 0.035 OTW PTA Balloon Catheter
• 00821684057544: 0.035 IN OTW PTA Balloon Catheter
• 00821684057537: 0.035 IN OTW PTA Balloon Catheter
• 00821684057520: 0.035 IN OTW PTA Balloon Catheter
• 00821684057513: 0.035 IN OTW PTA Balloon Catheter
• 00821684057506: 0.035 OTW PTA Balloon Catheter
• 00821684057490: 0.035 OTW PTA Balloon Catheter
• 00821684057483: 0.035 IN OTW PTA Balloon Catheter
• 00821684057476: 0.035 OTW PTA Balloon Catheter
• 00821684057469: 0.035 OTW PTA Balloon Catheter
• 00821684057452: 0.035 IN OTW PTA Balloon Catheter
• 00821684057445: 0.035 IN OTW PTA Balloon Catheter
• 00821684057438: 0.035 OTW PTA Balloon Catheter
• 00821684057421: 0.035 OTW PTA Balloon Catheter