Palindrome 8888145063

GUDID 10884521013421

SI Chronic Catheter Kit,Symmetrical Tip, Silver Ion Sleeve and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 23 cm

Covidien LP

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 10884521013421
• NIH Device Record Key: adb256ea-95d8-449a-85fd-e7d69c552b0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palindrome
• Version Model Number: 8888145063
• Catalog Number: 8888145063
• 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: true
• 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

Device Dimensions

• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 14.5 French
• Length: 23 Centimeter
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521013421 [Primary]
GS1	20884521013428 [Package]; Package: PACK_OR_INNER_PACK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112477

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: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-22

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• 10884521013025: H Chronic Catheter Sport Pack,Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet,14.5 Fr/C
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• 10884521158542: Precision RT Chronic Catheter Kit,Symmetrical Tip, Reverse-Tunneled,15 Fr/Ch (5.0 mm) x 55 cm
• 10884521158535: Precision RT Chronic Catheter Kit,Symmetrical Tip, Reverse-Tunneled,15 Fr/Ch (5.0 mm) x 44 cm
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• 20884521158488: Precision SI Chronic Catheter Kit,Symmetrical Tip, Silver Ion Sleeve,14.5 Fr/Ch (4.8 mm) x 44 cm
• 10884521158474: Precision SI Chronic Catheter Kit,Symmetrical Tip, Silver Ion Sleeve,14.5 Fr/Ch (4.8 mm) x 44 cm
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