Tandem-Cath 8888223266

GUDID 10884521009967

Chronic Dual Catheter System,23 cm Arterial Cuff / 26 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm)

Covidien LP

Double-lumen haemodialysis catheter, implantable
Primary Device ID10884521009967
NIH Device Record Keyec16e233-e64d-49a6-bb07-7a2eaf7b081d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandem-Cath
Version Model Number8888223266
Catalog Number8888223266
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 Kittrue
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
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

Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
Catheter Gauge10 French
Device Size Text, specify0
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521009967 [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 Number4
Public Version Date2021-02-05
Device Publish Date2014-09-22

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

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