FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160288334
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
KDAU227-01_0004
Catalog number
KDAU227-01
Published
2020-07-23
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

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
20809160288334PackageGS14In Commercial Distribution
10809160288337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916028833420809160288334
1080916028833710809160288337

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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
true
Combination product
false
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
10809160540862HalyardHOHD26-01_0006HOHD26-012026-10-20
10809160540886HalyardFBCH113-03_0007FBCH113-032026-10-20
10809160540893HalyardNAFB055-10_0004NAFB055-102026-10-20
10809160540909HalyardNAFB024-12_0006NAFB024-122026-10-20
10809160540916HalyardNAFB057-06_0004NAFB057-062026-10-20
10809160540923HalyardNAFB082-06_0003NAFB082-062026-10-20
10809160540930HalyardNAFB066-11_0003NAFB066-112026-10-20
10809160540947HalyardMSBS14-06MSBS14-062026-10-20
10809160540954HalyardSAMM022-22_0003SAMM022-222026-10-20
10809160540961HalyardVALV224-05_0014VALV224-052026-10-20
10809160540978HalyardVALV223-06_0008VALV223-062026-10-20
10809160540985HalyardSTVA013-06_0009STVA013-062026-10-20
10809160540787HalyardBPVP85-01_0002BPVP85-012026-10-19
10809160540794HalyardTNCA09_0007TNCA092026-10-19
10809160540800HalyardJCLC12F_0009JCLC12F2026-10-19
10809160540817HalyardMWOS97-02MWOS97-022026-10-19
10809160540824HalyardUSAR034-20_0013USAR034-202026-10-19
10809160540831HalyardEURO055-01_0007EURO055-012026-10-19
10809160540664HalyardDUDV85-02_0001DUDV85-022026-10-16
10809160540671HalyardDAGV13-03_0001DAGV13-032026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450113059Merit Medical®Merit Medical Systems, Inc.OEZ2026-10-20
10809160540909HalyardAVID MEDICAL, INC.OEZ2026-10-20
10198956441811CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956462328CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956516922CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956559226CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956584266CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589629CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956589896CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602151CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602205CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602649CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602786CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956602854CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956603844CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604346CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604476CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956604926CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606432CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606760CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956606890CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956607057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956607170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609013CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956609129CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956610583CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956611054CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19
10198956611252CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-19