FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160296295
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
BPHL802-04_0004
Catalog number
BPHL802-04
Published
2020-12-01
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160296292PackageGS112In Commercial Distribution
10809160296295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916029629220809160296292
1080916029629510809160296295

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) 564-7153AVIDComplaints@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
10809160527719HalyardKOOT801-03_0002KOOT801-032026-07-22
10809160527726HalyardLDSF0001_0004LDSF00012026-07-22
10809160527733HalyardLDSF0002_0002LDSF00022026-07-22
10809160527740HalyardLDSF0003_0002LDSF00032026-07-22
10809160527597HalyardBPTJ33-01_0006BPTJ33-012026-07-21
10809160527603HALYARDPVHM223-02PVHM223-022026-07-21
10809160527610HALYARDPVHM221-02PVHM221-022026-07-21
10809160527627HalyardHVBM208-02_0005HVBM208-022026-07-21
10809160527634HalyardBPMY56-02BPMY56-022026-07-21
10809160527641HalyardNHJV6000-22_0006NHJV6000-222026-07-21
10809160527658HalyardKOOT800-01_0003KOOT800-012026-07-21
10809160527672HalyardSHND401-05_0010SHND401-052026-07-21
10809160527689HalyardMEEP10-01_0008MEEP10-012026-07-21
10809160527696HalyardHVBM222-02_0003HVBM222-022026-07-21
10809160527702HalyardSGGR61-04_0002SGGR61-042026-07-21
10809160527542HalyardUSAR053-16_0001USAR053-162026-07-20
10809160527559HalyardSAMM034-21_0001SAMM034-212026-07-20
10809160527566HalyardWILF003-24_0004WILF003-242026-07-20
10809160527573HalyardAVMD057_0001AVMD0572026-07-20
10809160527580HalyardSAMM066-18_0001SAMM066-182026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376546Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450488751Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
00884450499276Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-22
10809160527719HalyardAVID MEDICAL, INC.OEZ2026-07-22
10809160527658HalyardAVID MEDICAL, INC.OEZ2026-07-21
10197106917619CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956119505CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956173552CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956326583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956343337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956346758CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956427723CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956439375CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956462045CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956487666CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956490031CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956492967CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956493742CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496248CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956496439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956500259CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956502673CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956504912CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956509665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956510463CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956512894CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956514942CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956515369CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956516359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20
10198956517035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-20