FDA.reportPublic FDA data

Medex

Primary DI
50351688501088
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MXG300162
Published
2016-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50351688501088PackageGS150In Commercial Distribution
10351688501080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850108850351688501088
1035168850108010351688501080

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06