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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
Arrow(R) VPS(R) Access Kit for use with 5 Fr. PICC FDA UDI
Model / Reference
IPN929360 FDA UDI
Description
Arrow(R) VPS(R) Access Kit for use with 5 Fr. PICC FDA UDI

Identifiers

Catalog Number
ASK-04001-UCHD1 FDA UDI
Primary DI / UDI-DI
10801902219005 FDA UDI
510(k) Number
K103255 FDA UDI
FDA Product Code
OBJ FDA UDI
GMDN Term
Vascular catheterization support/maintenance kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

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

K103255 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 c4383143-e294-4415-ad76-e85a51222ea6 37 fields · synced May 30, 2026