FDA.reportPublic FDA data

Halyard

Primary DI
20809160303723
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
ADVG036-04_0004
Catalog number
ADVG036-04
Published
2020-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961225000CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETBaxter Healthcare Corp1996-06-21FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160303723PackageGS125In Commercial Distribution
10809160303726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916030372320809160303723
1080916030372610809160303726

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160523063HalyardSFSLVTJ65-01_0001SFSLVTJ65-012026-06-09
10809160523070HalyardLVTJ65-01_0011LVTJ65-012026-06-09
10809160523087HalyardSFSMSBM022-06_0003SFSMSBM022-062026-06-09
10809160523094HalyardAXOG2000-11_0001AXOG2000-112026-06-09
10809160523100HalyardACTK56-03_0009ACTK56-032026-06-09
10809160523117HalyardSGGY67-05_0003SGGY67-052026-06-09
10809160523124HalyardBMHT020-05_0001BMHT020-052026-06-09
10809160523131HalyardSHAN409-06_0004SHAN409-062026-06-09
10809160523148HalyardAMCH001-02_0002AMCH001-022026-06-09
10809160523162HalyardDUCD44-03_0003DUCD44-032026-06-09
10809160523179HalyardLLHT24-01_0006LLHT24-012026-06-09
10809160523186HalyardLMCV54-01_0002LMCV54-012026-06-09
10809160523193HalyardUICD62-01_0004UICD62-012026-06-09
10809160523209HalyardRCOH61-01_0007RCOH61-012026-06-09
10809160523216HalyardUICS88-01_0002UICS88-012026-06-09
10809160523223HalyardUIPD03-01_0005UIPD03-012026-06-09
10809160523230HalyardWILF002-23_0005WILF002-232026-06-09
10809160523247HalyardWILF002-23_0006WILF002-232026-06-09
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08

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Primary DI, Brand, Company table
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08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
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04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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