FDA.reportPublic FDA data

Halyard

Primary DI
10809160527382
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BMGT003-03_0005
Catalog number
BMGT003-03
Published
2026-07-17
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

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
20809160527389PackageGS16In Commercial Distribution
10809160527382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052738920809160527389
1080916052738210809160527382

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160529188HalyardGBTK48-02_0005GBTK48-022026-08-07
10809160529195HalyardBKLS53-02_0004BKLS53-022026-08-07
10809160529201HalyardSGRB86-05_0011SGRB86-052026-08-07
10809160529218HalyardSGCB55-05_0001SGCB55-052026-08-07
10809160529225HalyardVMCC024-14_0008VMCC024-142026-08-07
10809160529232HalyardAKML42-02_0014AKML42-022026-08-07
10809160529249HalyardQPLP65-02_0004QPLP65-022026-08-07
10809160529256HalyardSFSAKML42-02_0001SFSAKML42-022026-08-07
10809160529263HalyardAKLE90-03_0002AKLE90-032026-08-07
10809160529270HalyardSFSAKLE90-03_0001SFSAKLE90-032026-08-07
10809160529287HalyardQPMN13-02_0011QPMN13-022026-08-07
10809160529294HalyardACTS62-02_0004ACTS62-022026-08-07
10809160529300HalyardACSH43-04_0002ACSH43-042026-08-07
10809160529317HalyardHVBM213-04_0004HVBM213-042026-08-07
10809160529324HalyardBMHT501-01_0011BMHT501-012026-08-07
10809160529331HalyardJACK428-07_0004JACK428-072026-08-07
10809160529348HalyardMSBM039-04_0004MSBM039-042026-08-07
10809160529355HalyardMCLP78-02_0007MCLP78-022026-08-07
10809160529362HalyardSELF134-05_0007SELF134-052026-08-07
10809160529379HalyardSELF133-07_0004SELF133-072026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160529362HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160529379HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160528402HalyardAVID MEDICAL, INC.OKV2026-08-03
10809160528471HalyardAVID MEDICAL, INC.OKV2026-08-03
10198956531307CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956534094CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956536999CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10809160528075HalyardAVID MEDICAL, INC.OKV2026-07-29
10809160527856HalyardAVID MEDICAL, INC.OKV2026-07-28
10198956499263CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10198956510937CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10809160527702HalyardAVID MEDICAL, INC.OKV2026-07-21
10198956532250CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-20
10809160527542HalyardAVID MEDICAL, INC.OKV2026-07-20
10809160527498HalyardAVID MEDICAL, INC.OKV2026-07-17
10198956486584CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-16
10809160527269HalyardAVID MEDICAL, INC.OKV2026-07-16
10198956388208CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-09
10809160526927HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526941HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526842HalyardAVID MEDICAL, INC.OKV2026-07-08
10809160526811HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526828HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526507HalyardAVID MEDICAL, INC.OKV2026-07-06
10809160526309HalyardAVID MEDICAL, INC.OKV2026-06-26
10809160525951HalyardAVID MEDICAL, INC.OKV2026-06-24
10198956485075CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-23
10809160525203HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525258HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525265HalyardAVID MEDICAL, INC.OKV2026-06-22