FDA.reportPublic FDA data

IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec

Primary DI
00646311490224
Brand
IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec
Company
SB-KAWASUMI LABORATORIES, INC.
Model
IV-027N
Published
2016-09-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00646311490224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00646311490224006463114902246463114902240646311490224

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690625850
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987488111298K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03090PP030902026-05-31
04987488111304K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X90PP01X902026-05-31
04987488111311K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03091PP030912026-05-31
04987488111328K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X91PP01X912026-05-31
04987488111335K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03000PP030002026-05-31
04987488111342K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X00PP01X002026-05-31
04987488111359K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03001PP030012026-05-31
04987488111366K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X01PP01X012026-05-31
04987488111373K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03020PP030202026-05-31
04987488111380K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X20PP01X202026-05-31
04987488111397K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP03021PP030212026-05-31
04987488111403K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingPP01X21PP01X212026-05-31
04545499074423SB Knife Jr2MD-477022026-04-06
04545499074430SB Knife Jr2 /Long typeMD-47702L2026-04-06
00646311400018WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-21GDBM1-21G2016-09-20
00646311400025WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-23GDBM1-23G2016-09-20
00646311400032WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTERDBM1-25GDBM1-25G2016-09-20
00646311410017SMALL VEIN INFUSION SETD3K1-21G1D3K1-21G12016-09-20
00646311410024SMALL VEIN INFUSION SETD3K1-23G1D3K1-23G12016-09-20
00646311410031SMALL VEIN INFUSION SETD3K1-25G1D3K1-25G12016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
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
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624601253Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921207Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921214Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921238Q2 Blood Administration SetsQUEST MEDICAL INCFPA2022-12-06
00634624921122High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-06
00634624921115High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-05
00634624911062Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-10-26
00634624921382Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921399Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921405Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921412Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921429Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921436Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921016Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921023Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921030Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921061Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921078Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624922044Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24