FDA.reportPublic FDA data

IV Plus

Primary DI
10815879021387
Brand
IV Plus
Company
NEXUS MEDICAL, LLC
Model
BS0657
Device description
Blunt Cannula in Blister Pack
Published
2021-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081123000NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETSNexus Medical, LLC2008-11-14FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815879021381PackageGS11000In Commercial Distribution
10815879021387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081587902138130815879021381
1081587902138710815879021387

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-866-336-3987TKOCUSTSERV@NEXUSMEDICAL.COM

Regulatory Flags#

DUNS number
169260325
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815879022001IV PlusN10842026-02-12
10815879021929IV PlusAD1002A2025-10-03
10892855000710Nexus NIS®N80002016-09-12
10815879021912 Nexus TKO®PTB6830N-2T2025-05-09
30815879021916 Nexus TKO®PTB6830N-2T2025-05-09
10815879021905IV PlusN20812025-04-23
30815879021909IV PlusN20812025-04-23
10815879021899IV PlusN20802025-04-03
30815879021893IV PlusN20802025-04-03
10815879021011IV Plus®BD60102017-06-09
10815879021882IV PlusN10912025-02-06
10815879021875IV PlusBS9903R2025-01-30
30815879021879IV PlusBS9903R2025-01-30
10815879021837IV PlusN10152024-12-17
10815879021844IV PlusN10202024-12-17
30815879021831IV PlusN10152024-12-17
30815879021848IV PlusN10202024-12-17
10815879021868 Nexus TKO®N4685MPHV-B2024-12-11
30815879021862 Nexus TKO®N4685MPHV-B2024-12-11
10815879021851IV PlusN10902024-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
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05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15