FDA.reportPublic FDA data

Medex

Primary DI
50351688507271
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX452FL
Published
2016-12-29
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
FPKTubing, fluid delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688507271PackageGS150In Commercial Distribution
10351688507273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850727150351688507271
1035168850727310351688507273

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
Radiation Sterilization

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
true
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
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21
10887709194080BivonaFT26EN35NGF164N2026-05-21
10887709194097BivonaFU26EN40NSE165N2026-05-21
10887709194103BivonaFT26EN60NGA166N2026-05-21
10887709194110BivonaFU26EN30NGE167N2026-05-21
10887709194127BivonaFU26EN30NGE170N2026-05-21
10887709194134BivonaFU26EN35NGE169N2026-05-21
00887709102460ICU Medical15687-2815687-282022-09-13
10887709192154BivonaZZ26DN35NGF198N2026-05-20
10887709193359BivonaZT26EN65NSZ072N2026-05-20
10887709193694BivonaZU26EN35NGE118N2026-05-20
10887709193779BivonaFU26DN35NGE237N2026-05-20
10887709193854BivonaFT26EN70NSC087N2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450628307Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
10192253003338MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003345MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003352MonojectCardinal Health 200, LLCFPK2024-08-21
00616258024554Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
00616258024561MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
00616258024820MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450325312Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2021-04-05
00849884005141VYGONVygon CorporationFPK2021-01-28
10849884002260VYGONVygon CorporationFPK2020-06-02
00849884002720VYGONVygon CorporationFPK2020-06-01
0063462495724425ft/7.6m IV Extension Set QUEST MEDICAL INCFPK2020-04-13
10849884002666VYGONVygon CorporationFPK2020-04-02
10849884002765VYGONVygon CorporationFPK2020-04-02
10849884002581VYGONVygon CorporationFPK2020-04-01
00849884004441VYGONVygon CorporationFPK2020-03-12
00849884003956VYGONVygon CorporationFPK2020-01-28
00849884004007VYGONVygon CorporationFPK2020-01-28
10351688507112MedexICU MEDICAL, INC.FPK2020-01-13
00849884000320VYGONVygon CorporationFPK2019-12-16
00849884000559VYGONVygon CorporationFPK2019-12-16
00849884000566VYGONVygon CorporationFPK2019-12-16
00634624957817Exoflex 10.5in. IVExtension Set QUEST MEDICAL INCFPK2019-12-09
00849884000269VYGONVygon CorporationFPK2019-11-14
00849884000313VYGONVygon CorporationFPK2019-11-14
00849884000375VYGONVygon CorporationFPK2019-11-14
00849884000443VYGONVygon CorporationFPK2019-11-14
00849884000450VYGONVygon CorporationFPK2019-11-14
00849884000467VYGONVygon CorporationFPK2019-11-14
00849884000535VYGONVygon CorporationFPK2019-11-14