FDA.reportPublic FDA data

Medex

Primary DI
10351688500557
Brand
Medex
Company
ICU MEDICAL, INC.
Model
SM5014
Published
2017-01-03
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943897000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943897000NU-SITEMedex, Inc.1995-02-10FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688500555PackageGS1100In Commercial Distribution
10351688500557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850055550351688500555
1035168850055710351688500557

GMDN Terms#

Term, Definition table
TermDefinition
In-line backflow valve, single-useA general-purpose device used in medical or laboratory tubing to prevent the backflow of gases or liquids. It will typically have a small ball or a leaf valve that instantly closes should a retrograde pressure (backflow) occur. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
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05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
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00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
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