FDA.report

Halyard

Primary DI
20809160346140
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
ESJH001-02_0002
Catalog number
ESJH001-02
Published
2021-03-03
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

Related Records

Contact Domains

Product Codes

CodeName
OESCardiac catheterization kit

Product Code Classifications

CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160346140PackageGS120In Commercial Distribution
10809160346143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916034614020809160346140
1080916034614310809160346143

GMDN Terms

TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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 DIBrandModelCatalogPublished
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10809160521847HalyardAVID MEDICAL, INC.OES2026-05-26
10198956478855CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956485457CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956486775CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
10198956488618CARDINAL HEALTHCardinal Health 200, LLCOES2026-05-25
20809160517236HalyardAVID MEDICAL, INC.OES2026-03-24
50198956364194CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956380385CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956415070CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
50198956433234CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-23
20809160517120HalyardAVID MEDICAL, INC.OES2026-03-23
20809160516871HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516895HalyardAVID MEDICAL, INC.OES2026-03-20
20809160516956HalyardAVID MEDICAL, INC.OES2026-03-20
50198956404272CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956410518CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
50198956412826CARDINAL HEALTHCardinal Health 200, LLCOES2026-03-19
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40198459616632MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
40198459616649MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16
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40198459619770MEDLINEMEDLINE INDUSTRIES, INC.OES2026-03-16