FDA.reportPublic FDA data

Halyard

Primary DI
20809160375638
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
FHCS14S_0002
Catalog number
FHCS14S
Published
2022-07-06
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160375638PackageGS17In Commercial Distribution
10809160375631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916037563820809160375638
1080916037563110809160375631

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. 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
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 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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956441880CARDINAL HEALTHCardinal Health 200, LLCOKV2026-05-25
10198956482388CARDINAL HEALTHCardinal Health 200, LLCOKV2026-05-25
50198956426854CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-24
50198956358407CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956396638CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956424461CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956424720CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
50198956425482CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-23
20809160517168HalyardAVID MEDICAL, INC.OKV2026-03-23
20809160517199HalyardAVID MEDICAL, INC.OKV2026-03-23
20809160516758HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516765HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516772HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516826HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516963HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516970HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160517021HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160517083HalyardAVID MEDICAL, INC.OKV2026-03-20
20809160516697HalyardAVID MEDICAL, INC.OKV2026-03-19
20809160516703HalyardAVID MEDICAL, INC.OKV2026-03-19
50198956329889CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-16
20809160516222HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160516260HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160516277HalyardAVID MEDICAL, INC.OKV2026-03-16
20809160515966HalyardAVID MEDICAL, INC.OKV2026-03-12
50198956363043CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956393316CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956411010CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-10
50198956405910CARDINAL HEALTHCardinal Health 200, LLCOKV2026-03-09
20809160515270HalyardAVID MEDICAL, INC.OKV2026-03-09