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X-Port duo M.R.I.

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
X-Port duo M.R.I. FDA UDI
Generic Name
Vascular port/catheter FDA UDI
Device Name
X-Port Duo M.R.I. Implantable Port with Attachable 9.5F Dual-Lumen Venous Catheter Intermediate Kit FDA UDI
Model / Reference
0607650 FDA UDI
Description
X-Port Duo M.R.I. Implantable Port with Attachable 9.5F Dual-Lumen Venous Catheter Intermediate Kit FDA UDI

Identifiers

Catalog Number
0607650 FDA UDI
Primary DI / UDI-DI
00801741026225 FDA UDI
FDA Product Code
LJT FDA UDI
GMDN Term
Vascular port/catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5965 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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 50 Centimeter FDA UDI
Catheter Gauge — 9.5 French FDA UDI

Category: Vascular port/catheter

X-Port duo M.R.I. by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular port/catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI 70859ab8-cd91-4e55-99d3-be2d5ca33816 36 fields · synced Jun 9, 2026