FDA.reportPublic FDA data

Portex

Primary DI
00351688047574
Brand
Portex
Company
ICU MEDICAL, INC.
Model
4917M-19
Published
2017-01-09
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
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092657000EPIFUSE CATHETER CONNECTOR, MODEL: 4909ESmiths Medical Asd, Inc.2009-11-04CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688047571PackageGS110In Commercial Distribution
00351688047574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035168804757110351688047571
00351688047574003516880475743516880475740351688047574

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, non-sterileA small, non-sterile device intended to create a mechanical union between a catheter and an external device (e.g., external drainage system) typically via a Luer connection; it is not dedicated to a specific type of catheter. It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709198033BivonaFT26GN40NGE057N2026-07-13
10887709198040BivonaXA26GS70NSC058N2026-07-13
10887709198057BivonaFT26GN35NGE060N2026-07-13
10887709198071BivonaFT26GN60NSC063N2026-07-13
10887709198088BivonaFT26GN45NGF056N2026-07-13
10887709198125BivonaFT26GN35NSE071N2026-07-13
10887709198132BivonaFT26GN35NSE072N2026-07-13
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902202243ARROWTELEFLEX INCORPORATEDCAZ2026-07-13
04048223070116UniPlex® NanoLine®Pajunk GmbH MedizintechnologieCAZ2026-06-10
04048223073056EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074787EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074800EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223084182EpiLong NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088005SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088050PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088661SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088692SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088708PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088722PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223089873LOR NRFit 10ml, SlipPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223090466EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223125267SonoLong SoftSecurePajunk GmbH MedizintechnologieCAZ2026-06-10
10193489490312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAZ2022-08-04
10193489031768MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031775MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031799MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
04048223116869PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223116883PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117088STIMULONG SONOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117187PLEXOLONG NANOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117309SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117422SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
10381780464792Integra®INTEGRA PAIN MANAGEMENTCAZ2018-07-16
10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431640Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431657Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22