FDA.reportPublic FDA data

Halyard

Primary DI
10809160348369
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SWMR005-05_0001
Catalog number
SWMR005-05
Published
2021-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160348366PackageGS12In Commercial Distribution
10809160348369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916034836620809160348366
1080916034836910809160348369

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

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
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
10809160527191HalyardLIFE0091-12_0001LIFE0091-122026-07-16
10809160527207HalyardLIFE0242-02_0003LIFE0242-022026-07-16
10809160527214HalyardBMHT400-02_0008BMHT400-022026-07-16
10809160527221HalyardBMHT400-02_0009BMHT400-022026-07-16
10809160527238HalyardSGBS30-02SGBS30-022026-07-16
10809160527245HalyardDGCC52-03_0001DGCC52-032026-07-16
10809160527252HalyardLANC062-06_0001LANC062-062026-07-16
10809160527269HalyardVATX033-02_0001VATX033-022026-07-16
10809160527276HalyardMAMC222-16_0001MAMC222-162026-07-16
10809160527283HalyardPVHM214-02PVHM214-022026-07-16
10809160527290HalyardPVHM211-01PVHM211-012026-07-16
10809160527306HalyardLIFE0157-05_0001LIFE0157-052026-07-16
10809160527047HalyardLMLP08-01_0002LMLP08-012026-07-14
10809160527061HalyardKDAU216-02_0011KDAU216-022026-07-14
10809160527085HalyardDULP19_0005DULP192026-07-14
10809160527092HalyardAKCY76-01_0005AKCY76-012026-07-14
10809160527009HalyardBMHT101-05_0001BMHT101-052026-07-13
10809160527016HalyardBMHT103-05_0001BMHT103-052026-07-13
10809160527023HalyardBMHT102-03_0001BMHT102-032026-07-13
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956344020CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956418431CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956439887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956444386CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956462175CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956472105CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477391CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956509689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956510548CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956510661CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956513679CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956518223CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956520707CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956522787CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956525412CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956525818CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956526457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956526525CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527188CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527317CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527652CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527768CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16