FDA.reportPublic FDA data

Halyard

Primary DI
10809160482483
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
BUTK82-01
Catalog number
BUTK82-01
Published
2025-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160482483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916048248310809160482483

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, 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

Sterilization Methods#

Method table
Method

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
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
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10193489213911Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJH2023-06-08
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