FDA.reportPublic FDA data

Cathivex-GV

Primary DI
04054839076541
Brand
Cathivex-GV
Company
MERCK MILLIPORE LIMITED
Model
SLGV0250S
Published
2016-09-22
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
FPBFilter, Infusion Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPBFilter, Infusion LineGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143583000Cathivex ¿GV filter unitsMerck Millipore , Ltd.2015-08-11FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054839076541PrimaryGS10
04054839078057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054839076541040548390765414054839076541
04054839078057040548390780574054839078057

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line filterA sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896873994
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436037123160Dualex Transducer ProtectorSLGVS25XS2015-09-04
04053252397837Millex - FHSLFH1000N2015-09-04
04053252398018Dualex Plus Transducer ProtectorSLGVS25PS2015-09-01
04053252660283Dualex Ultra Transducer ProtectorSLGVS25US2015-09-04
04053252725180HydromillexSLST025DM2015-09-04
04054839076473Millex - FHSLFH1000N2016-09-01
04054839076565Dualex Plus Transducer ProtectorSLGVS25PS2016-09-01
04054839076572Dualex Ultra Transducer ProtectorSLGVS25US2016-09-01
04054839076756HydromillexSLST025DM2016-09-01
04054839078217Dualex Transducer ProtectorSLGVS25XS2016-09-01
04053252359194Multiscreen-HTS HVMSHVN45102023-10-13
04053252466274Multiscreen-HTS HVMSHVN45502023-10-13
04053252504501Multiscreen-HVMAHVN45102023-10-13
04053252505928Multiscreen-HVMAHVN45502023-10-13
04054839076251Millex-AASLAAM33SS2016-09-22
04054839076497Millex-GPSLGPM33RS2016-09-22
04054839076510Millex-GSSLGSM33SS2016-09-22
04054839076558Millex-GVSLGVM33RS2016-09-22
04054839076596Millex-HASLHAM33SS2016-09-22
04054839076602Millex-HPSLHPM33RS2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00849884006179VYGONVygon CorporationFPB2023-06-05
00849884006186VYGONVygon CorporationFPB2023-06-05
30849884006170VYGONVygon CorporationFPB2023-06-05
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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
28426314391416GRI-BAGLABORATORIOS GRIFOLS SAFPB2021-10-26
00849884005035VYGONVygon CorporationFPB2021-01-22
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30849884005036VYGONVygon CorporationFPB2021-01-22
30849884005043VYGONVygon CorporationFPB2021-01-22
00085412639338EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-10-21
00085412639444FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412653297EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
00085412660387EXTENSION SETBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
50085412639449FLUID SYSTEMS ACCESSORIESBAXTER HEALTHCARE CORPORATIONFPB2020-09-30
10849884002604VYGONVygon CorporationFPB2020-04-01
30849884002608VYGONVygon CorporationFPB2020-04-01
00849884004328VYGONVygon CorporationFPB2020-01-27
30849884004329VYGONVygon CorporationFPB2020-01-27
00849884000337VYGONVygon CorporationFPB2019-12-16
30849884000338VYGONVygon CorporationFPB2019-12-16
00849884000504VYGONVygon CorporationFPB2019-11-14
30849884000505VYGONVygon CorporationFPB2019-11-14
00849884002775VYGONVygon CorporationFPB2019-11-01
30849884002776VYGONVygon CorporationFPB2019-11-01