Power-Trialysis catheter

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name: Power-Trialysis catheter FDA UDI
Generic Name: Triple-lumen haemodialysis catheter FDA UDI
Device Name: 13Fr Trialysis PC 15cm Kit FDA UDI
Model / Reference: 5613150 FDA UDI
Description: 13Fr Trialysis PC 15cm Kit FDA UDI

Identifiers

Catalog Number: 5613150 FDA UDI
Primary DI / UDI-DI: 00801741041945 FDA UDI
FDA Product Code: NIE FDA UDI
GMDN Term: Triple-lumen haemodialysis catheter 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 13 French FDA UDI
Length — 15 Centimeter FDA UDI

Category: Triple-lumen haemodialysis catheter

Power-Trialysis catheter by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bard Access Systems, Inc.

Sources (1)

FDA UDI beefa83a-2df7-4359-b3d2-fc68f4a0c8f7 36 fields · synced Jun 9, 2026