EverCross AB35W03040135

GUDID 00821684039571

.035

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00821684039571
• NIH Device Record Key: 03a8a581-e134-49f1-b99e-c64fee5b0141
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EverCross
• Version Model Number: AB35W03040135
• Catalog Number: AB35W03040135
• 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: 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3 Millimeter
• Length: 40 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0

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
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684039571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103322

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 [EverCross]

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• 00821684045985: .035
• 00821684045978: .035
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• 00821684045886: .035
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• 00821684044728: .035
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• 00821684044704: .035
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• 00821684039984: .035
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• 00821684039946: .035