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BD Angiocath IV Catheter, BD Insyte IV Catheter

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K151698Ref 381154Ref 381137Ref 381147Ref 381157Ref 381112Ref 381123Ref 381167

by Becton Dickinson Infusion Therapy Systems Inc.

Identity

Trade Name
ANGIOCATH EUDAMED
BD Angiocath FDA UDI
BD Angiocath IV Catheter FDA UDI
Generic Name
Peripheral intravenous cannula FDA UDI
Device Name
BD Angiocath™ IV Catheter EUDAMED
ANGIOCATH GRAY 16GA X 1.16IN FDA UDI
ANGIOCATH BL 22GA X 1.0IN FDA UDI
ANGIOCATH YEL 24GA X 0.75IN FDA UDI
ANGIOCATH GRAY 16GA X 1.88IN FDA UDI
ANGIOCATH GN 18GA X 1.88IN FDA UDI
ANGIOCATH ORN 14GA X 1.88IN FDA UDI
ANGIOCATH PNK 20GA X 1.88IN FDA UDI
Model / Reference
381154 EUDAMEDFDA UDI
381123 EUDAMEDFDA UDI
381112 EUDAMEDFDA UDI
381157 EUDAMEDFDA UDI
381147 EUDAMEDFDA UDI
381167 EUDAMEDFDA UDI
381137 EUDAMEDFDA UDI
Description
ANGIOCATH GRAY 16GA X 1.16IN FDA UDI
ANGIOCATH BL 22GA X 1.0IN FDA UDI
ANGIOCATH YEL 24GA X 0.75IN FDA UDI
ANGIOCATH GRAY 16GA X 1.88IN FDA UDI
ANGIOCATH GN 18GA X 1.88IN FDA UDI
ANGIOCATH ORN 14GA X 1.88IN FDA UDI
ANGIOCATH PNK 20GA X 1.88IN FDA UDI

Identifiers

Catalog Number
381154 FDA UDI
381123 FDA UDI
381112 FDA UDI
381157 FDA UDI
381147 FDA UDI
381167 FDA UDI
381137 FDA UDI
Primary DI / UDI-DI
00382903811540 EUDAMEDFDA UDI
00382903811236 EUDAMEDFDA UDI
00382903811120 EUDAMEDFDA UDI
00382903811571 EUDAMEDFDA UDI
00382903811472 EUDAMEDFDA UDI
00382903811670 EUDAMEDFDA UDI
00382903811373 EUDAMEDFDA UDI
Basic UDI-DI
038290PLUSQXZORT EUDAMED
510(k) Number
K151698 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)FDA UDI
EMDN Code
C0101010102 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
GMDN Term
Peripheral intravenous cannula FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)FDA UDI
Market of Registration
Poland EUDAMED
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 30 Millimeter FDA UDI
Length — 25 Millimeter FDA UDI
Length — 19 Millimeter FDA UDI
Length — 48 Millimeter FDA UDI

The BD Angiocath IV Catheter and BD Insyte IV Catheter are peripheral venous catheters designed for intravenous access. These devices facilitate the administration of fluids, medications, and blood products, as well as blood sampling and monitoring of central venous pressure. They are engineered for reliable insertion and secure placement within veins, ensuring effective and safe infusion therapy.

These catheters are supplied sterile and intended for single-use only. They are classified under product code FOZ and comply with FDA 510(k) clearance and EU MDR regulations. Available in various sizes and gauges, they are intended for use in general hospital settings and must be stored under appropriate conditions to maintain sterility and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Becton Dickinson – Wikipedia, BD (company) - Wikipedia

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
FDA Applicant
Becton Dickinson Infusion Therapy Systems, Inc.

Sources (15)

  • FDA 510(k) K151698 24 fields · synced Sep 18, 2026
  • FDA UDI 19272810-8ca8-4332-bc53-22948564397a 36 fields · synced May 29, 2026
  • FDA UDI 4ae53147-c302-4912-bc7e-0408574a1679 36 fields · synced May 30, 2026
  • FDA UDI 3f0bdc0b-d9e0-4876-a6b4-90a3de15eb10 36 fields · synced May 30, 2026
  • FDA UDI 60462eaa-7a65-4299-ba39-88c937e32ff4 36 fields · synced May 30, 2026
  • FDA UDI a6a857bc-11aa-43b3-a1ea-999f28b29924 36 fields · synced May 30, 2026
  • FDA UDI 319b853a-3577-46f1-a376-0bbeb07625e3 36 fields · synced May 30, 2026
  • FDA UDI 1d4a6cb1-1c10-4095-8ee7-a4f9c825cf41 36 fields · synced May 30, 2026
  • EUDAMED ca513446-63fd-458e-840a-b94d40d0827d 61 fields · synced Jul 9, 2026
  • EUDAMED 78d2bb91-0628-4769-b3eb-63fbf0ba575e 61 fields · synced Jul 9, 2026
  • EUDAMED 971e9850-867a-4b60-9aa5-9aec3a97d030 61 fields · synced Jul 9, 2026
  • EUDAMED 157a70b1-0ae8-4395-ae32-ccee9806a039 61 fields · synced Jul 12, 2026
  • EUDAMED 610545ea-336e-44b3-8076-7a4818bb0a5a 61 fields · synced Jul 22, 2026
  • EUDAMED 9b31bc59-449a-467b-8b85-74c640f72dd3 61 fields · synced Aug 4, 2026
  • EUDAMED f19ac51f-3068-4c1d-b95c-5417781cf2da 61 fields · synced Sep 18, 2026