Medex

Primary DI
10351688508010
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX342
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912709000MX 339 TWIN HEMOSTATIC Y CONNECTORMedex, Inc.1991-09-11DTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688508018PackageGS125In Commercial Distribution
10351688508010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850801850351688508018
1035168850801010351688508010

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
10887709201016BivonaFU26HN30NSE091N2026-08-19
10887709201450BivonaFT26HN40NSF114N2026-08-19
10887709201504BivonaFT26HN30NSE122N2026-08-19
10887709201528BivonaFU26HN45NSA120N2026-08-19
10887709201535BivonaFU26HN40NSF117N2026-08-19
10887709201542BivonaFT26HN35NGF123N2026-08-19
10887709201559BivonaFT26HN50NSA119N2026-08-19
10887709201566BivonaFT26HN40NGF124N2026-08-19
10887709201573BivonaHT26HS80NSB126N2026-08-19
10887709201603BivonaFP26HN25NGE127N2026-08-19
10887709201610BivonaSU26HN35TGE116N2026-08-19
10887709201351BivonaAA26HS60NGC079N2026-08-18
10887709201368BivonaFT26HN60NGF108N2026-08-18
10887709201375BivonaFT26HN40NGF109N2026-08-18
10887709201399BivonaFU26HN60NGA111N2026-08-18
10887709201405BivonaFT26HN35NSA113N2026-08-18
10887709201412BivonaFT26HN40NGA090N2026-08-18
10887709201429BivonaFT26GN45NSF190N2026-08-18
10887709201436BivonaFU26HN30NGA098N2026-08-18
10887709201443BivonaFU26HN25NSA099N2026-08-18

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Primary DI, Brand, Company table
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