FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160285487
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
AVMD018_0014
Catalog number
AVMD018
Published
2020-06-15
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160285487PackageGS110In Commercial Distribution
10809160285480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916028548720809160285487
1080916028548010809160285480

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of sterile devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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
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
10809160531853HalyardDGAL24-03_0010DGAL24-032026-08-27
10809160531860HalyardDGBB41-02_0006DGBB41-022026-08-27
10809160531877HalyardDGIV63_0008DGIV632026-08-27
10809160531884HalyardDUAD22-01_0004DUAD22-012026-08-27
10809160531891HalyardDUCC54_0009DUCC542026-08-27
10809160531907HalyardDUEC27-01_0004DUEC27-012026-08-27
10809160531914HalyardSJGH109-07_0007SJGH109-072026-08-27
10809160531921HalyardSFSEURO028-07_0001SFSEURO028-072026-08-27
10809160531938HalyardSHND415-02_0001SHND415-022026-08-27
10809160531945HalyardSOTJ41-01_0007SOTJ41-012026-08-27
10809160531952HalyardNAMC425-08_0013NAMC425-082026-08-27
10809160531969HalyardWAFB224-03_0007WAFB224-032026-08-27
10809160531976HalyardSFSBAAK106-15_0001SFSBAAK106-152026-08-27
10809160531983HalyardSFSEABF007-15_0001SFSEABF007-152026-08-27
10809160531990HalyardSFSBUAH026-24_0001SFSBUAH026-242026-08-27
10809160532003HalyardSFSEAMC114-07_0001SFSEAMC114-072026-08-27
10809160532010HalyardWRNM004-18_0004WRNM004-182026-08-27
10809160532027HalyardEURO002-11_0005EURO002-112026-08-27
10809160532034HalyardSFSEURO010-10_0001SFSEURO010-102026-08-27
10809160532041HalyardEURO013-11_0005EURO013-112026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531884HalyardAVID MEDICAL, INC.OES2026-08-27
10809160531891HalyardAVID MEDICAL, INC.OES2026-08-27
10198956557901CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956557918CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956561762CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10809160531679HalyardAVID MEDICAL, INC.OES2026-08-26
10809160531273HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531280HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531396HalyardAVID MEDICAL, INC.OES2026-08-21
10809160530801HalyardAVID MEDICAL, INC.OES2026-08-19
10198956546301CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
10198956554481CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
B098AMS188600Aligned Medical SolutionsAligned Medical SolutionsOES2026-08-03
10198956543287CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956543614CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956544550CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10809160528259HalyardAVID MEDICAL, INC.OES2026-07-31
10198956517776CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956534926CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956535404CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10809160527672HalyardAVID MEDICAL, INC.OES2026-07-21
10198956528062CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-20
10809160527580HalyardAVID MEDICAL, INC.OES2026-07-20
10809160527436HalyardAVID MEDICAL, INC.OES2026-07-17
10198956335523CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956509283CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956524880CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529083CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10198956529410CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-16
10809160527252HalyardAVID MEDICAL, INC.OES2026-07-16