Tandem-Cath 8888200006

GUDID 20884521009940

Chronic Dual Catheter System Repair Kit,Back-End,10 Fr/Ch (3.3 mm)

Covidien LP

Double-lumen haemodialysis catheter, implantable
Primary Device ID20884521009940
NIH Device Record Key90760a73-4b5f-4274-96e9-dc764fae7334
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem-Cath
Version Model Number8888200006
Catalog Number8888200006
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French
Catheter Gauge10 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS120884521009940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSDCatheter, hemodialysis, implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

On-Brand Devices [Tandem-Cath]

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

Trademark Results [Tandem-Cath]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TANDEM-CATH
TANDEM-CATH
78035291 2799065 Live/Registered
COVIDIEN AG
2000-11-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.