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FDA UDIEUDAMED

Class II (US FDA UDI)

Ref CV-12122-UF

by Teleflex Incorporated

Identity

Trade Name
You-Bend(TM) Two-Lumen Hemodialysis Catheter for High Volume Infusions EUDAMED
ARROW FDA UDI
Generic Name
Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Device Name
AHDC Procedure Pack EUDAMED
You-Bend(TM) Two-Lumen Hemodialysis Catheter for High Volume Infusions FDA UDI
Model / Reference
CV-12122-UF EUDAMED
IPN919945 FDA UDI
Description
You-Bend(TM) Two-Lumen Hemodialysis Catheter for High Volume Infusions FDA UDI

Identifiers

Catalog Number
CV-12122-UF FDA UDI
Primary DI / UDI-DI
10801902190472 EUDAMEDFDA UDI
Basic UDI-DI
08019020000000000000046KG EUDAMED
510(k) Number
K991431 FDA UDI
FDA Product Code
MPB FDA UDI
EMDN Code
C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
GMDN Term
Double-lumen haemodialysis catheter, nonimplantable FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
876.5540 FDA UDI
Medical Purpose
The large-bore two-lumen catheter permits venous access to the central circulation for temporary or short-term hemodialysis and apheresis. It may be inserted in the jugular subclavian or femoral veins. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Double-lumen haemodialysis catheter, nonimplantable

Arrow by Teleflex Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Double-lumen haemodialysis catheter, nonimplantable.

Cleared under the same submission

K991431 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (2)

  • FDA UDI f561918e-3bcf-4dea-b5cb-97ac07a8b922 36 fields · synced Oct 6, 2026
  • EUDAMED 7fd3ccd6-71bf-470b-b38a-79c631e8082f 61 fields · synced Jul 15, 2026