FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160290408
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
VAPX013-04_0006
Catalog number
VAPX013-04
Published
2020-08-25
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
10809160290408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916029040810809160290408

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

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
Combination product
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
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539392HALYARDGBCC47-02GBCC47-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956587298CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-01
10809160539569HalyardAVID MEDICAL, INC.OEZ2026-10-01
10197106980361CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956485105CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956563247CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956565913CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956568167CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956575745CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956578999CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956589209CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956590083CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592285CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592599CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592636CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592704CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956592810CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593688CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956593961CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956594623CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956595255CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596078CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956596153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10198956598225CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-30
10809160539392HALYARDAVID MEDICAL, INC.OEZ2026-09-30
10809160539408HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539460HalyardAVID MEDICAL, INC.OEZ2026-09-30
10809160539484HalyardAVID MEDICAL, INC.OEZ2026-09-30
00884450421383Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450431917Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29
00884450500002Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-29