FDA.reportPublic FDA data

VYGON

Primary DI
00849884005035
Brand
VYGON
Company
Vygon Corporation
Model
AMS-423-1
Catalog number
AMS-423-1
Device description
"12"" STANDARDBORE EXTENSION SET WITH 1.2 MICRON FILTER"
Published
2021-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K894954000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894954000.22 & 1.2 MICRON IV FILTERSChurchill Medical Systems, Inc.1989-11-13FPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884005036PackageGS150In Commercial Distribution
00849884005035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400503630849884005036
00849884005035008498840050358498840050350849884005035

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.

Regulatory Flags#

DUNS number
120818216
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849884007619VYGONAMS-9869CSAMS-9869CS2026-08-31
00849884007718VYGONMS022MS0222026-10-19
00849884007770VYGONPIP100000TPIP100000T2026-10-09
08498840001691VYGONAMS-6180CPAMS-6180CP2016-08-09
08498840001707VYGONAMS-6186CPAMS-6186CP2016-08-09
08498840002148VYGONAMS-7192CS-2AMS-7192CS-22016-09-15
08498840002735VYGONAMS-8133AMS-81332016-09-07
08498840002889VYGONAMS-8180-3CPAMS-8180-3CP2016-09-07
08498840002902VYGONAMS-8181CPAMS-8181CP2016-09-07
08498840002940VYGONAMS-8198-1AMS-8198-12016-09-15
08498840002957VYGONAMS-8198CSAMS-8198CS2016-09-15
08498840002964VYGONAMS-8199AMS-81992016-09-15
08498840003213VYGONAMS-8280CP-4AMS-8280CP-42016-09-15
08498840003688VYGONAMS-8423CPAMS-8423CP2016-09-07
08498840004005VYGONAMS-8485CP-1AMS-8485CP-12016-09-15
08498840004333VYGONAMS-8712CP-1AMS-8712CP-12016-09-02
08498840004784VYGONAMS-9093CPAMS-9093CP2016-09-02
08498840004814VYGONAMS-9152CPAMS-9152CP2016-09-02
08498840004951VYGONAMS-923CPAMS-923CP2016-09-02
08498840005071VYGONAMS-9294AMS-92942016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15034480300925Pall Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315752Pall Lipipor NLF1A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315769Pall Lipipor NLF2A Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
15034480315776Pall Lipipor NLF2NTA Infusion FilterGlobal Life Sciences Solutions USA LLCFPB2026-09-21
46975124930965 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.FPB2026-04-11
00859695006084WalkMed InfusionWALKMED TECHNOLOGIES, LLCFPB2025-09-12
00849884006179VYGONVygon CorporationFPB2023-06-05
00849884006186VYGONVygon CorporationFPB2023-06-05
30849884006170VYGONVygon CorporationFPB2023-06-05
30849884006187VYGONVygon CorporationFPB2023-06-05
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
00849884005042VYGONVygon CorporationFPB2021-01-22
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