FDA.reportPublic FDA data

Medex

Primary DI
10351688509932
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX152072
Published
2016-10-11
Public version status
Update
Distribution status
Not 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
FMFSyringe, piston
FPASet, administration, intravascular
FPBFilter, infusion line
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2
FPBFilter, Infusion LineGeneral Hospital2
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688509930PackageGS175Not in Commercial Distribution
10351688509932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850993050351688509930
1035168850993210351688509932

GMDN Terms#

Term, Definition table
TermDefinition
Low-resistance epidural syringeA low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. 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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
08426314391399GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391474GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
08426314391481GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
07640138981593RegenKit-THT-3/RegenCell®REGEN LAB SAFMF2021-10-26
G001S10000ShifengChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.FMF2020-12-01
G001S30000ShifengChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.FMF2020-11-17
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
07640138980244RegenKit®-THT-1/RegenCell®REGEN LAB SAFMF2019-06-17
07640138980251RegenKit®-THT-4/RegenCell®REGEN LAB SAFMF2019-06-17
07640138980565RegenKit®-THT-2/RegenCell®REGEN LAB SAFMF2019-06-17
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
08498840000014VYGONVygon CorporationFPA2017-07-28
08498840001172VYGONVygon CorporationFPA2017-07-05
08426314580816GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314583503GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314604031GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314575683GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05
08426314575690GRI-BAGLABORATORIOS GRIFOLS SAFPB2017-04-05