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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, implantable FDA UDI
Device Name
Cannon(R) II Plus Catheter Replacement Hub FDA UDI
Model / Reference
IPN920495 FDA UDI
Description
Cannon(R) II Plus Catheter Replacement Hub FDA UDI

Identifiers

Catalog Number
CAR-02800 FDA UDI
Primary DI / UDI-DI
20801902195337 FDA UDI
510(k) Number
K020430 FDA UDI
FDA Product Code
NFK 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Double-lumen haemodialysis catheter, implantable

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, implantable.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI e2e2524e-1fab-4aba-b21f-5cda9b7ab5b6 36 fields · synced Jun 8, 2026