8888200001

GUDID 10884521056282

Acute and Chronic Catheter Repair Kit,Palindrome Chronic Care and all MAHURKAR Acute and Chronic Care Catheters

Covidien LP

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 10884521056282
• NIH Device Record Key: aed33ae0-c1cb-4ad7-8029-626ff1832d11
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8888200001
• Catalog Number: 8888200001
• 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
• 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
• 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: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521056282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092797

FDA Product Code

• NFK: Kit, repair, catheter, hemodialysis

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: 2021-02-05
• Device Publish Date: 2015-08-31

Devices Manufactured by Covidien LP

• 20884521841724 - Shiley: 2026-03-25 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Proximal with Disposable Inner Cannula
• 20884521841687 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula
• 20884521841694 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula
• 20884521841700 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula
• 20884521841717 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Distal with Disposable Inner Cannula
• 20884521841731 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Proximal with Disposable Inner Cannula
• 20884521841748 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Proximal with Disposable Inner Cannula
• 20884521841755 - Shiley: 2026-03-24 Adult Flexible Tracheostomy Tube XLT with TaperGuard (TM) Cuff Proximal with Disposable Inner Cannula