FDA.reportPublic FDA data

HALYARD

Primary DI
10809160525890
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
BMHT600
Catalog number
BMHT600
Published
2026-06-23
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160525897PackageGS14In Commercial Distribution
10809160525890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052589720809160525897
1080916052589010809160525890

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

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
10809160542224HalyardMARS002-06_0002MARS002-062026-10-29
10809160542231HalyardSOLC12A-01_0005SOLC12A-012026-10-29
10809160542248HalyardASAB78-04_0002ASAB78-042026-10-29
10809160542163HALYARDHHIR34-03HHIR34-032026-10-28
10809160542200HalyardEURO017-11_0003EURO017-112026-10-28
10809160541944HALYARDMSMC123-04MSMC123-042026-10-27
10809160541548HalyardVAPX008-09_0018VAPX008-092026-10-26
10809160541555HalyardVAPX007-09_0021VAPX007-092026-10-26
10809160541562HalyardVAPX012-07_0009VAPX012-072026-10-26
10809160541579HalyardVAPX014-08_0012VAPX014-082026-10-26
10809160541586HalyardVAPX015-12_0016VAPX015-122026-10-26
10809160541593HalyardSAMM021-12_0008SAMM021-122026-10-26
10809160541609HalyardUSAR042-23_0002USAR042-232026-10-26
10809160541616HalyardVAPX013-06_0013VAPX013-062026-10-26
10809160541623HalyardVAPX018-12_0014VAPX018-122026-10-26
10809160541630HalyardVAPX019-07_0029VAPX019-072026-10-26
10809160541647HalyardVAPX020-09_0020VAPX020-092026-10-26
10809160541654HalyardVAPX022-06_0021VAPX022-062026-10-26
10809160541661HalyardVAPX019-07_0001VAPX019-072026-10-26
10809160541678HalyardVAPX036-07_0027VAPX036-072026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956609877CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-29
10198956612587CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-29
10809160542040HalyardMEDICAL ACTION INDUSTRIES INC.OES2026-10-28
10809160541944HALYARDAVID MEDICAL, INC.OES2026-10-27
10198956593077CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956611504CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956534834CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605237CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605343CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608009CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608191CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10809160541159HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541241HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541302HalyardAVID MEDICAL, INC.OES2026-10-22
10198956518964CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956584419CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956590298CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956608702CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10809160540688HalyardAVID MEDICAL, INC.OES2026-10-16
10198956606203CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-13
10809160540596HalyardAVID MEDICAL, INC.OES2026-10-13
10198956592766CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956597518CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598416CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598522CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598539CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602311CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602748CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10809160540145HalyardAVID MEDICAL, INC.OES2026-10-08
10198956593817CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06