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Tandem-Cath

FDA UDI

Class II (US FDA UDI)

by Mozarc Medical US LLC

Identity

Trade Name
Tandem-Cath FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
Chronic Dual Catheter System,19 cm Arterial Cuff / 22 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm) FDA UDI
Model / Reference
8888219226 FDA UDI
Description
Chronic Dual Catheter System,19 cm Arterial Cuff / 22 cm Venous Cuff, Sideholes,10 Fr/Ch (3.3 mm) FDA UDI

Identifiers

Primary DI / UDI-DI
20884521009957 FDA UDI
510(k) Number
K041006 FDA UDI
FDA Product Code
MSD FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, implantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 10 French FDA UDI

Category: Double-lumen haemodialysis catheter, implantable

Tandem-Cath by Mozarc Medical US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, implantable.

Cleared under the same submission

K041006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mozarc Medical US LLC

Sources (1)

  • FDA UDI 4b62600e-a522-44eb-a4c3-e58d713fd8c1 36 fields · synced Jun 8, 2026