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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Vascular catheterization support/maintenance kit, non-medicated FDA UDI
Device Name
Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included) FDA UDI
Model / Reference
IPN930503 FDA UDI
Description
Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included) FDA UDI

Identifiers

Catalog Number
ASK-04001-BW2 FDA UDI
Primary DI / UDI-DI
10801902221602 FDA UDI
510(k) Number
K914531 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Vascular catheterization support/maintenance kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 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

Yes

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

Category: Vascular catheterization support/maintenance kit, non-medicated

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

Similar devices

Also classified as Vascular catheterization support/maintenance kit, non-medicated.

Cleared under the same submission

K914531 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 b8df632a-220f-4138-a930-2781bbdc1e51 37 fields · synced Jun 1, 2026