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Nexiva

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref 383691Ref 383693510(k) K173354Ref 383641

by Becton Dickinson Infusion Therapy Systems Inc.

Identity

Trade Name
Nexiva EUDAMED
BD Nexiva™ Closed IV Catheter System FDA UDI
Generic Name
Peripheral intravenous cannula FDA UDI
Device Name
BD Nexiva™ Diffusics™ Closed IV Catheter System EUDAMED
BD Nexiva™ Closed IV Catheter System - Dual Port with Cap EUDAMED
BD Nexiva™ Closed IV Catheter System 24GA x 0.75IN FDA UDI
Model / Reference
383691 EUDAMED
383693 EUDAMED
383641 EUDAMEDFDA UDI
Description
BD Nexiva™ Closed IV Catheter System 24GA x 0.75IN FDA UDI

Identifiers

Catalog Number
383641 FDA UDI
Primary DI / UDI-DI
00382903836918 EUDAMED
00382903836932 EUDAMED
00382903836413 EUDAMEDFDA UDI
Basic UDI-DI
038290KJKZSYMBJP EUDAMED
038290BTGFDFRO57 EUDAMED
510(k) Number
K173354 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)FDA UDI
EMDN Code
C01010103 PERIPHERAL I.V. CATHETERS, WITH INTEGRATED EXTENSIONS 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
Spain 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

Yes

EUDAMEDEUDAMED

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

Nexiva by Becton Dickinson Infusion Therapy Systems Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
EUDAMED SRN
US-MF-000017719
Authorised Representative
Becton Dickinson Ireland Limited IE-AR-000007610

Sources (5)

  • EUDAMED 3ca68941-5428-4e7d-b1b6-6f99edda8220 61 fields · synced Sep 17, 2026
  • EUDAMED aa8f9c61-d7bd-4548-9b8c-e22ace7528c6 61 fields · synced May 18, 2026
  • FDA 510(k) K173354 24 fields · synced May 18, 2026
  • FDA UDI 79c535a1-a9ac-4877-8809-1b233b869536 34 fields · synced May 30, 2026
  • EUDAMED a155b31e-a170-40a2-9539-3e62e2ff7ebd 61 fields · synced Jul 8, 2026