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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Central venous catheterization kit, short-term FDA UDI
Device Name
Pressure Injectable Arrowg+ard Blue Plus(R) Two-Lumen CVC Kit / PSI Kit for use with 8 - 8.5 Fr. Catheters FDA UDI
Model / Reference
IPN028395 FDA UDI
Description
Pressure Injectable Arrowg+ard Blue Plus(R) Two-Lumen CVC Kit / PSI Kit for use with 8 - 8.5 Fr. Catheters FDA UDI

Identifiers

Catalog Number
ASK-42802-SM FDA UDI
Primary DI / UDI-DI
10801902143201 FDA UDI
FDA Product Code
FOZ FDA UDI
GMDN Term
Central venous catheterization kit, short-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 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

Yes

FDA UDI

Category: Central venous catheterization kit, short-term

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

Similar devices

Also classified as Central venous catheterization kit, short-term.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 29ac8cf3-66c7-44f6-9ce7-f5652fd484bc 36 fields · synced May 30, 2026