FDA.reportPublic FDA data

Medex

Primary DI
10351688516879
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MXG300230
Published
2016-10-13
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
CBTArterial blood sampling kit
DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR
FPBFilter, infusion line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1
DPTProbe, Blood-Flow, ExtravascularCardiovascular2
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070340000
K790314000
K942377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070340000SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.2007-03-15CBT
K790314000FLUID ADMINISTRATION SETS, 15 MICRONMedex, Inc.1979-03-06FPB
K942377000TRANSTAR PRESSURE TRANSDUCERMedex, Inc.1994-08-16DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688516877PackageGS110In Commercial Distribution
10351688516879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168851687750351688516877
1035168851687910351688516879

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. 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
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

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Primary DI, Brand, Company table
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08426314391399GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
10190752154612AirLife™AIRLIFECBT2021-06-21
10190752154681AirLife™AIRLIFECBT2021-06-21
10190752154704AirLife™VYAIRE MEDICAL, INC.CBT2021-06-21
10190752154728AirLife™AIRLIFECBT2021-06-21
10190752154735AirLife™AIRLIFECBT2021-06-21
10190752154742AirLife™AIRLIFECBT2021-06-21
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10190752154827AirLife™AIRLIFECBT2021-06-21
10190752154858AirLife™VYAIRE MEDICAL, INC.CBT2021-06-21
10190752154995AirLife™AIRLIFECBT2021-06-21
10190752155008AirLife™AIRLIFECBT2021-06-21
10190752155015AirLife™AIRLIFECBT2021-06-21
10190752155046AirLife™VYAIRE MEDICAL, INC.CBT2021-06-21
10190752155053AirLife™AIRLIFECBT2021-06-21
10190752155060AirLife™AIRLIFECBT2021-06-21
10193489190502MEDLINEMEDLINE INDUSTRIES, INC.CBT2020-05-04
10193489191462MEDLINEMEDLINE INDUSTRIES, INC.CBT2020-04-20
08498840011522VYGONVygon CorporationCBT2020-03-12
10351688504234MedexICU MEDICAL, INC.CBT2020-01-13
08498840010310VYGONVygon CorporationFPB2017-07-28
08498840010327VYGONVygon CorporationFPB2017-07-28
08498840010686VYGONVygon CorporationFPB2017-07-28
08426314580816GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05