Chameleon

GUDID 10884521812307

PTA Balloon Catheter with Injection Port

Covidien LP

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic 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