FDA.reportPublic FDA data

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
10809160541340HalyardMMBF002-03_0006MMBF002-032026-10-23
10809160541357HalyardVATX010-15_0013VATX010-152026-10-23
10809160541364HalyardMMBF007-04_0004MMBF007-042026-10-23
10809160541371HalyardMMBF006-07_0010MMBF006-072026-10-23
10809160541388HalyardMMBF017-05_0005MMBF017-052026-10-23
10809160541395HalyardMMBF027-01_0010MMBF027-012026-10-23
10809160541401HalyardMMBF024-02_0003MMBF024-022026-10-23
10809160541418HalyardMMBF016-06_0005MMBF016-062026-10-23
10809160541425HalyardMMBF008-04_0009MMBF008-042026-10-23
10809160541432HalyardMMBF010-04_0003MMBF010-042026-10-23
10809160541449HalyardMMBR003-02_0028MMBR003-022026-10-23
10809160541456HalyardMMBR007-02_0017MMBR007-022026-10-23
10809160541463HalyardMMBR002-02_0028MMBR002-022026-10-23
10809160541111HalyardMMSY007-02_0006MMSY007-022026-10-22
10809160541128HalyardSHAN099-01_0002SHAN099-012026-10-22
10809160541142HalyardOGHT55-02OGHT55-022026-10-22
10809160541159HalyardMMTN019-02_0016MMTN019-022026-10-22
10809160541166HalyardVATX013-13_0004VATX013-132026-10-22
10809160541173HalyardMMNP007-03_0010MMNP007-032026-10-22
10809160541180HalyardVATX015-10_0009VATX015-102026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
23700550400763Qitexio 4-Way StopcockMEDEXFMG2025-05-09
00382903949106Connecta, Luer-LokBD Switzerland SàrlFMG2023-09-21
00887709126794ICU MedicalICU MEDICAL, INC.FMG2023-07-10
00887709126800ICU MedicalICU MEDICAL, INC.FMG2023-06-21
00634624921092High-Flow 4-Way StopcockQUEST MEDICAL INCFMG2022-12-06
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
00840619005955ICU MedicalICU MEDICAL, INC.FMG2021-08-24
00840619000028ICU MedicalICU MEDICAL, INC.FMG2021-08-03
00840619000042ICU MedicalICU MEDICAL, INC.FMG2021-08-03
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
04046955665075Extension SetB. BRAUN MEDICAL INC.FMG2021-02-08
10193489191684MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10193489191707MEDLINEMEDLINE INDUSTRIES, INC.FMG2020-04-15
10888439636703CARDINAL HEALTHCardinal Health 200, LLCFMG2019-12-17
10653160330936CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFMG2019-11-05
04046955270347IV Administration SetB. BRAUN MEDICAL INC.FMG2019-02-22
10653160323679CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFMG2019-01-05
00690103199093FloTrac IQ, VAMP OptimaEdwards Lifesciences LLCFMG2018-11-20
00690103199161FloTrac IQ, VAMP OptimaEdwards Lifesciences LLCFMG2018-11-20