Chameleon

GUDID 10884521812307

PTA Balloon Catheter with Injection Port

Covidien LP

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 10884521812307
• NIH Device Record Key: ab3b8317-0ebe-4795-a530-4a3ef1434e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chameleon
• Version Model Number: CH09-40-75US
• Company DUNS: 058614483
• 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: true
• 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
• 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

• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Catheter Gauge: 5.9 French
• Length: 40 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 1216 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521812307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170635

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: 2021-11-29
• Device Publish Date: 2021-11-20

On-Brand Devices [Chameleon]

• 10884521812321: PTA Balloon Catheter with Injection Port
• 10884521812314: PTA Balloon Catheter with Injection Port
• 10884521812307: PTA Balloon Catheter with Injection Port
• 10884521812291: PTA Balloon Catheter with Injection Port
• 10884521812277: PTA Balloon Catheter with Injection Port
• 10884521812260: PTA Balloon Catheter with Injection Port
• 10884521812284: PTA Balloon Catheter with Injection Port