FDA.reportPublic FDA data

Halyard

Primary DI
10809160429013
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
RYCB72-03_0027
Catalog number
RYCB72-03
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160429013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916042901310809160429013

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

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
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
10809160521700HalyardDULP98-02_0001DULP98-022026-05-21
10809160521717HalyardLHMB9513-01_0004LHMB9513-012026-05-21
10809160521724HalyardNIHB0021-13_0003NIHB0021-132026-05-21
10809160521649HalyardNIHB0009-11_0007NIHB0009-112026-05-20
10809160521656HalyardNIHB0021-13_0011NIHB0021-132026-05-20
10809160521663HalyardNIHB0026-10_0003NIHB0026-102026-05-20
10809160521670HalyardNIHB0036-08_0006NIHB0036-082026-05-20
10809160521687HalyardNIHB0024-08_0006NIHB0024-082026-05-20
10809160521694HalyardWINN121-11_0002WINN121-112026-05-20
10809160521618HalyardSLCL55-02_0002SLCL55-022026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H65857031555Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031565Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031315Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-10
H65857030865Henry ScheinHENRY SCHEIN, INC.OEZ2022-05-25
H65857029425Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
H65857029535Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
10193489040166NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040180NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040197NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040203NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040210NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040227NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040234NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040241NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040258NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040265NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040272NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040289NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040296NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040302NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040319NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040326NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040333NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040340NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040357NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040364NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040371NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040388NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040395NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040401NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28