Tandem-Cath

Basic Information

• Brand Name: Tandem-Cath
• Primary DI: 10884521009967
• Version / Model: 8888223266
• Catalog Number: 8888223266
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-22
• Public Version: 6
• Public Version Date: 2023-06-29
• Public Version Status: Update
• Public Device Record Key: ec16e233-e64d-49a6-bb07-7a2eaf7b081d
• Distribution End Date: 2020-10-06

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSD	Catheter, hemodialysis, implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37278	Double-lumen haemodialysis catheter, implantable	An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521009967	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K041006	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length,23 cm Arterial Cuff,N/A;Length,26 cm Venous Cuff,N/A;
Catheter Gauge	10	French