FDA.reportPublic FDA data

Medex

Primary DI
10351688508843
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX20815
Published
2016-10-19
Public version status
Update
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
FPBFilter, infusion line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790314000FLUID ADMINISTRATION SETS, 15 MICRONMedex, Inc.1979-03-06FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688508841PackageGS125In Commercial Distribution
10351688508843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850884150351688508841
1035168850884310351688508843

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended 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, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
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
46975124930965 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.FPB2026-04-11
00859695006084WalkMed InfusionWALKMED TECHNOLOGIES, LLCFPB2025-09-12
00849884006179VYGONVygon CorporationFPB2023-06-05
00849884006186VYGONVygon CorporationFPB2023-06-05
30849884006170VYGONVygon CorporationFPB2023-06-05
30849884006187VYGONVygon CorporationFPB2023-06-05
08426314391399GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
28426314391416GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
00849884005035VYGONVygon CorporationFPB2021-01-22
00849884005042VYGONVygon CorporationFPB2021-01-22
30849884005036VYGONVygon CorporationFPB2021-01-22
30849884005043VYGONVygon CorporationFPB2021-01-22
00085412639338EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-10-21
00085412639444FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412653297EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412660387EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
50085412639449FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
10849884002604VYGONVygon CorporationFPB2020-04-01
30849884002608VYGONVygon CorporationFPB2020-04-01
00849884004328VYGONVygon CorporationFPB2020-01-27
30849884004329VYGONVygon CorporationFPB2020-01-27
00849884000337VYGONVygon CorporationFPB2019-12-16
30849884000338VYGONVygon CorporationFPB2019-12-16
00849884000504VYGONVygon CorporationFPB2019-11-14
30849884000505VYGONVygon CorporationFPB2019-11-14
00849884002775VYGONVygon CorporationFPB2019-11-01
30849884002776VYGONVygon CorporationFPB2019-11-01