FDA.reportPublic FDA data

Halyard

Primary DI
10809160312223
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
KAFB003-17_0012
Catalog number
KAFB003-17
Published
2020-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10809160312223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916031222310809160312223

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
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489426694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489427516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489428605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489430660Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489431643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489445053Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489447002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454505Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489455076Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489455663Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489420708Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-04-30
10193489429442Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-09-04
10193489344844Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-08-04
10195327132132Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-08-04
10195327133320Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-08-04
10193489424607Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2022-07-17