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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Device Name
Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions FDA UDI
Model / Reference
IPN030088 FDA UDI
Description
Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions FDA UDI

Identifiers

Catalog Number
CS-15122-E FDA UDI
Primary DI / UDI-DI
00801902001122 FDA UDI
510(k) Number
K993933 FDA UDI
FDA Product Code
MPB FDA UDI
GMDN Term
Double-lumen haemodialysis catheter, nonimplantable 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

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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 20 Centimeter FDA UDI
Catheter Gauge — 12 French FDA UDI

Category: Double-lumen haemodialysis catheter, nonimplantable

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

Similar devices

Also classified as Double-lumen haemodialysis catheter, nonimplantable.

Cleared under the same submission

K993933 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 389ac6c2-a010-4cbb-bb3c-1476c064ff87 38 fields · synced May 30, 2026