Arterial Wand

FDA UDI

Class II (US FDA UDI)

by Access Scientific, Inc.

Identity

Trade Name: ARTERIAL WAND FDA UDI
Generic Name: Peripheral vascular catheter FDA UDI
Device Name: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology FDA UDI
Model / Reference: 3Fr x 5cm FDA UDI
Description: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology FDA UDI

Identifiers

Catalog Number: 96001 FDA UDI
Primary DI / UDI-DI: 00859821006698 FDA UDI
510(k) Number: K181563 FDA UDI
FDA Product Code: DYB FDA UDI
DQY FDA UDI
GMDN Term: Peripheral vascular catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 FDA UDI
870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Dimensions & Sizes

Size: Needle Gauge — 21 Gauge FDA UDI
Catheter Gauge — 3 French FDA UDI
Catheter Length — 5 Centimeter FDA UDI

Category: Peripheral vascular catheter

Arterial Wand by Access Scientific, Inc. — 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
ARROW — TELEFLEX INCORPORATED · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Access Scientific, Inc.

Sources (1)

FDA UDI 20dd937d-639a-4b97-8d14-05129c601527 37 fields · synced May 30, 2026