FDA.reportPublic FDA data

Nexus NIS®

Primary DI
10892855000918
Brand
Nexus NIS®
Company
NEXUS MEDICAL, LLC
Model
N6073-NB
Device description
"7"" Microbore Extension Set with Non-Bonded Nexus NIS®-6 & Slide Clamp"
Published
2016-09-12
Public version status
Update
Distribution status
Not 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
K113398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113398000NEXUS TKO-6, LUER-ACTIVATED DEVICENexus Medical, LLC2012-04-18FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30892855000912PackageGS1100Not in Commercial Distribution
10892855000918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3089285500091230892855000912
1089285500091810892855000918

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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

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Primary DI, Brand, Company table
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00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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00811505030573IvenixFresenius Kabi AGFPA2026-06-02
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