FDA.reportPublic FDA data

Halyard

Primary DI
10809160411261
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
JACK435-04_0001
Catalog number
JACK435-04
Published
2023-11-06
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
10809160411261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916041126110809160411261

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160521878HalyardWBAM040-06_0005WBAM040-062026-05-27
10809160521885HalyardNAFB074-03_0006NAFB074-032026-05-27
10809160521892HalyardNAFB062-08_0002NAFB062-082026-05-27
10809160521908HalyardAKCR19-02_0005AKCR19-022026-05-27
10809160521915HalyardWINN104-09_0005WINN104-092026-05-27
10809160521922HalyardJACK401-09_0005JACK401-092026-05-27
10809160521939HalyardKDAU209-02_0012KDAU209-022026-05-27
10809160521946HalyardTPAH21-01_0011TPAH21-012026-05-27
10809160521953HalyardKDAU229-01_0007KDAU229-012026-05-27
10809160521960HalyardEABF016-06_0006EABF016-062026-05-27
10809160521977HalyardHHTK38-01_0010HHTK38-012026-05-27
10809160521984HalyardUFCF028-01_0008UFCF028-012026-05-27
10809160521991HalyardSGMN13-03_0009SGMN13-032026-05-27
10809160522004HalyardDUUE43-02_0010DUUE43-022026-05-27
10809160522011HalyardOSSP27-01_0009OSSP27-012026-05-27
10809160522028HalyardDUUR35-01_0005DUUR35-012026-05-27
10809160522035HALYARDAMCH001-02AMCH001-022026-05-27
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521984HalyardAVID MEDICAL, INC.OEZ2026-05-27
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