Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: ARROW FDA UDI
Generic Name: Peripheral vascular catheter FDA UDI
Device Name: ARROW(R) Midline with Chlorag+ard(R) Technology FDA UDI
Model / Reference: IPN037698 FDA UDI
Description: ARROW(R) Midline with Chlorag+ard(R) Technology FDA UDI

Identifiers

Catalog Number: CDC-41552-MPK1A FDA UDI
Primary DI / UDI-DI: 10801902130164 FDA UDI
510(k) Number: K161313 FDA UDI
FDA Product Code: PND FDA UDI
GMDN Term: Peripheral vascular catheter 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Peripheral vascular catheter

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

Similar devices

Also classified as Peripheral vascular catheter.

Arterial Line Kit — Argon Medical Devices, Inc. · Class I
DELTAVEN — DELTA MED SPA · Class II
EXEL Safelet Catheter — Exel International · Class II
Jelco — ICU MEDICAL, INC. · Class II
DELTAVEN — DELTA MED SPA · Class II
EXEL Safelet Catheter — Exel International · Class II
POWERWAND — ICU MEDICAL, INC. · Class II
POWERWAND — Access Scientific, Inc. · Class II

Cleared under the same submission

K161313 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 1c68e2e4-e188-42a1-a15c-66288925b556 36 fields · synced May 30, 2026