FDA.reportPublic FDA data

AVID TruCustom

Primary DI
20809160170806
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
LASV003-04_0011
Catalog number
LASV003-04
Published
2017-11-21
Public version status
Update
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
20809160170806PackageGS12In Commercial Distribution
10809160170809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916017080620809160170806
1080916017080910809160170809

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
10809160521700HalyardDULP98-02_0001DULP98-022026-05-21
10809160521717HalyardLHMB9513-01_0004LHMB9513-012026-05-21
10809160521724HalyardNIHB0021-13_0003NIHB0021-132026-05-21
10809160521649HalyardNIHB0009-11_0007NIHB0009-112026-05-20
10809160521656HalyardNIHB0021-13_0011NIHB0021-132026-05-20
10809160521663HalyardNIHB0026-10_0003NIHB0026-102026-05-20
10809160521670HalyardNIHB0036-08_0006NIHB0036-082026-05-20
10809160521687HalyardNIHB0024-08_0006NIHB0024-082026-05-20
10809160521694HalyardWINN121-11_0002WINN121-112026-05-20
10809160521618HalyardSLCL55-02_0002SLCL55-022026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H65857031555Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031565Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-25
H65857031315Henry ScheinHENRY SCHEIN, INC.OEZ2022-08-10
H65857030865Henry ScheinHENRY SCHEIN, INC.OEZ2022-05-25
H65857029425Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
H65857029535Henry ScheinHENRY SCHEIN, INC.OEZ2022-03-31
10193489040166NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040180NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040197NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040203NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040210NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040227NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040234NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040241NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040258NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040265NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040272NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040289NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040296NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040302NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040319NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040326NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040333NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040340NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040357NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040364NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040371NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040388NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040395NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28
10193489040401NAMICMEDLINE INDUSTRIES, INC.OEZ2021-10-28