Tandem-Cath 8888228316

GUDID 20884521009971

Chronic Dual Catheter System,28 cm Arterial Cuff / 31 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm)

Covidien LP

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 20884521009971
• NIH Device Record Key: 12201508-7d3b-4380-8d08-a934652664fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem-Cath
• Version Model Number: 8888228316
• Catalog Number: 8888228316
• 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: 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

Device Dimensions

• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0
• Catheter Gauge: 10 French
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	20884521009971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041006

FDA Product Code

• MSD: Catheter, hemodialysis, implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-22

On-Brand Devices [Tandem-Cath]

• 20884521009971: Chronic Dual Catheter System,28 cm Arterial Cuff / 31 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm
• 20884521009957: Chronic Dual Catheter System,19 cm Arterial Cuff / 22 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm
• 20884521009940: Chronic Dual Catheter System Repair Kit,Back-End,10 Fr/Ch (3.3 mm)
• 10884521009967: Chronic Dual Catheter System,23 cm Arterial Cuff / 26 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm