FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160201800
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
LGHM052-04_0001
Catalog number
LGHM052-04
Published
2018-07-23
Public version status
Update
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
20809160201807PackageGS14In Commercial Distribution
10809160201800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916020180720809160201807
1080916020180010809160201800

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
00884450161777Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
00884450432075Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-16
10198956319929CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956326484CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956382381CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956395886CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956424524CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956446533CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956502376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956505148CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956508378CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956512740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956513648CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956514508CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956519992CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956525337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526242CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956526778CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527782CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527836CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956527898CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528130CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528277CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528376CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528505CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528512CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528642CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16
10198956528833CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-16