FDA.reportPublic FDA data

Set, Administration, Intravascular

Primary DI
00858641006161
Brand
Set, Administration, Intravascular
Company
LIFE SCIENCE OUTSOURCING, INC.
Model
FL1002-FM
Published
2016-05-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K982587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982587000MPS FIXED FLOW RATE SETMedical Product Specialists1998-08-24FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858641006161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858641006161008586410061618586410061610858641006161

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017149456
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
00858641006000Set, IV, Fluid Transfer1 Pharm-62016-04-26
00858641006017Set, IV, Fluid Transfer1 Pharm-6FG2016-04-26
00858641006055Set, i.V. Fluid Transfer19MMTP2016-05-03
00858641006086Set, I.V. Fluid Transfer19TPV2016-05-03
00858641006024Syringe, Piston18B2016-04-26
00858641006048Ser, administration, intravascular19CHTP2016-05-03
00858641006079Set, Administration, Intravascular19TP2016-05-03
00858641006093Set, Administration, IntravascularDC-006-012016-05-03
00858641006109Set, Administration, IntravascularDC-012-012016-05-03
00858641006116Set, Administration, IntravascularDD-001-142016-05-03
00858641006130Set, Administration, IntravascularEB-060-022016-05-03
00858641006147Set, Administration, IntravascularEI-060-202016-05-03
00858641006154Set, Administration, IntravascularFL1000-FM2016-05-03
00858641006178Set, Administration, IntravascularFS-175B2016-05-03
00858641006185Set, Administration, IntravascularSM-0132016-05-03
00858641006192Set, Administration, IntravascularSM-0162016-05-03
00858641006031Needle, hypodermic, single lumen19B2016-05-03
00858641006062Set, Administration, Intravascular19MPT2016-05-05
00858641006208Set, Administration, IntravascularEB-060-262017-03-29
00085641006123Syringe, PistonDD-001-252016-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
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
04046955836406Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06