FDA.reportPublic FDA data

IV Plus

Primary DI
10815879021561
Brand
IV Plus
Company
NEXUS MEDICAL, LLC
Model
P5861N-60STP
Device description
"Trifurcated Extension Set with (1) Nexus NIS®-6P, 0.22-micron Filter and 60"" Stopcock Leg with (2) Nexus NIS®-6P "
Published
2022-12-06
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

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
K080976000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080976000NEXUS I.V. FLUID TRANSFER DEVICENexus Medical, LLC2008-11-10LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815879021565PackageGS150In Commercial Distribution
10815879021561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081587902156530815879021565
1081587902156110815879021561

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.

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
Primary DIBrandCompanyProduct codePublished
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08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840010266Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010372Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30