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12f Duo-Flow And 14f Duo-Flow 400xl Cathters Schon Xl/Femoral Sidebyside12f Duo-

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
12F DUO-FLOW AND 14F DUO-FLOW 400XL CATHTERS SCHON XL/FEMORAL SIDEBYSIDE12F DUO- FDA UDI
Generic Name
Double-lumen haemodialysis catheter, implantable FDA UDI
Device Name
14F X 20CM 400XL14F X 20CM 400XL W/CURVED EXTENSIONSW/CURVED EXTE BASIC SETBASIC SET FDA UDI
Model / Reference
DDFXL148CES FDA UDI
Description
14F X 20CM 400XL14F X 20CM 400XL W/CURVED EXTENSIONSW/CURVED EXTE BASIC SETBASIC SET FDA UDI

Identifiers

Catalog Number
DDFXL148CES FDA UDI
Primary DI / UDI-DI
00884908142679 FDA UDI
FDA Product Code
MPB 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

Category: Double-lumen haemodialysis catheter, implantable

12f Duo-Flow And 14f Duo-Flow 400xl Cathters Schon Xl/Femoral Sidebyside12f Duo- by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Double-lumen haemodialysis catheter, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI 0322db5a-4ea6-47f8-9d4d-06a1d04e4363 35 fields · synced May 31, 2026