Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: ARROW FDA UDI
Generic Name: Centrally-inserted central venous catheter FDA UDI
Device Name: Arrowg+ard Blue Advance(TM) JACC FDA UDI
Model / Reference: IPN037627 FDA UDI
Description: Arrowg+ard Blue Advance(TM) JACC FDA UDI

Identifiers

Catalog Number: JRT-43563-HPHNM FDA UDI
Primary DI / UDI-DI: 10801902129335 FDA UDI
510(k) Number: K161765 FDA UDI
FDA Product Code: LJS FDA UDI
GMDN Term: Centrally-inserted central venous catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5970 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Catheter Gauge — 6 French FDA UDI

Category: Centrally-inserted central venous catheter

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

Similar devices

Also classified as Centrally-inserted central venous catheter.

Cook — COOK INCORPORATED · Class II
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Groshong — Bard Access Systems, Inc. · Class II
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VYGON — VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG · Class II
VYGON — VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG · Class II
Hickman TriFusion — Bard Access Systems, Inc. · Class II
PowerHickman — Bard Access Systems, Inc. · Class II

Cleared under the same submission

K161765 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 03bb2d80-6b82-403b-9ffc-1b4a2c8468b8 38 fields · synced Jun 6, 2026