AVID TruCustom

Primary DI
10809160045657
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
ADVH064-02_0002
Published
2016-09-15
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
FMGStopcock, i.V. Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953573000ICU STOPCOK WITH EXTENSION TUBINGIcu Medical, Inc.1995-10-07FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160045654PackageGS150In Commercial Distribution
10809160045657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916004565420809160045654
1080916004565710809160045657

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line stopcockA sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Kit
true
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
10809160529188HalyardGBTK48-02_0005GBTK48-022026-08-07
10809160529195HalyardBKLS53-02_0004BKLS53-022026-08-07
10809160529201HalyardSGRB86-05_0011SGRB86-052026-08-07
10809160529218HalyardSGCB55-05_0001SGCB55-052026-08-07
10809160529225HalyardVMCC024-14_0008VMCC024-142026-08-07
10809160529232HalyardAKML42-02_0014AKML42-022026-08-07
10809160529249HalyardQPLP65-02_0004QPLP65-022026-08-07
10809160529256HalyardSFSAKML42-02_0001SFSAKML42-022026-08-07
10809160529263HalyardAKLE90-03_0002AKLE90-032026-08-07
10809160529270HalyardSFSAKLE90-03_0001SFSAKLE90-032026-08-07
10809160529287HalyardQPMN13-02_0011QPMN13-022026-08-07
10809160529294HalyardACTS62-02_0004ACTS62-022026-08-07
10809160529300HalyardACSH43-04_0002ACSH43-042026-08-07
10809160529317HalyardHVBM213-04_0004HVBM213-042026-08-07
10809160529324HalyardBMHT501-01_0011BMHT501-012026-08-07
10809160529331HalyardJACK428-07_0004JACK428-072026-08-07
10809160529348HalyardMSBM039-04_0004MSBM039-042026-08-07
10809160529355HalyardMCLP78-02_0007MCLP78-022026-08-07
10809160529362HalyardSELF134-05_0007SELF134-052026-08-07
10809160529379HalyardSELF133-07_0004SELF133-072026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00634624921108High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921160High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921191High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921184High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
00634624921245High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFMG2022-11-30
10193489896824Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMG2022-08-04
00840619006174ICU MedicalICU MEDICAL, INC.FMG2021-10-05
00840619006136ICU MedicalICU MEDICAL, INC.FMG2021-08-29
00840619005955ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006020ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619006075ICU MedicalICU MEDICAL, INC.FMG2021-08-24
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00840619023232ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023249ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619023263ICU MedicalICU MEDICAL, INC.FMG2021-08-24
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00840619001537ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001650ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001742ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619001773ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00749756310734DeRoyalDEROYAL INDUSTRIES, INC.FMG2021-07-12
00634624911017Q2 High Flow StopcockQUEST MEDICAL INCFMG2021-05-12
20634624911028Q2 High Flow Stopcock, BNSQUEST MEDICAL INCFMG2021-05-12
10193489191684MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10193489191707MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
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