FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160209479
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
VAML011-03_0005
Catalog number
VAML011-03
Published
2018-09-14
Public version status
New
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160209476PackageGS13In Commercial Distribution
10809160209479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916020947620809160209476
1080916020947910809160209479

GMDN Terms#

Term, Definition table
TermDefinition
Coronary optical coherence tomography systemAn assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.

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
10809160541548HalyardVAPX008-09_0018VAPX008-092026-10-26
10809160541555HalyardVAPX007-09_0021VAPX007-092026-10-26
10809160541562HalyardVAPX012-07_0009VAPX012-072026-10-26
10809160541579HalyardVAPX014-08_0012VAPX014-082026-10-26
10809160541586HalyardVAPX015-12_0016VAPX015-122026-10-26
10809160541593HalyardSAMM021-12_0008SAMM021-122026-10-26
10809160541609HalyardUSAR042-23_0002USAR042-232026-10-26
10809160541616HalyardVAPX013-06_0013VAPX013-062026-10-26
10809160541623HalyardVAPX018-12_0014VAPX018-122026-10-26
10809160541630HalyardVAPX019-07_0029VAPX019-072026-10-26
10809160541647HalyardVAPX020-09_0020VAPX020-092026-10-26
10809160541654HalyardVAPX022-06_0021VAPX022-062026-10-26
10809160541661HalyardVAPX019-07_0001VAPX019-072026-10-26
10809160541678HalyardVAPX036-07_0027VAPX036-072026-10-26
10809160541685HalyardVAPX035-06_0016VAPX035-062026-10-26
10809160541692HalyardVAPX125-06_0017VAPX125-062026-10-26
10809160541708HalyardDNUR81_0007DNUR812026-10-26
10809160541715HalyardVAPX126-02_0019VAPX126-022026-10-26
10809160541340HalyardMMBF002-03_0006MMBF002-032026-10-23
10809160541357HalyardVATX010-15_0013VATX010-152026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956593077CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956611504CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-26
10198956534834CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605237CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956605343CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608009CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10198956608191CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-23
10809160541159HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541241HalyardAVID MEDICAL, INC.OES2026-10-22
10809160541302HalyardAVID MEDICAL, INC.OES2026-10-22
10198956518964CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956584419CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956590298CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10198956608702CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-19
10809160540688HalyardAVID MEDICAL, INC.OES2026-10-16
10198956606203CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-13
10809160540596HalyardAVID MEDICAL, INC.OES2026-10-13
10198956592766CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956597518CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598416CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598522CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956598539CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602311CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10198956602748CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-12
10809160540145HalyardAVID MEDICAL, INC.OES2026-10-08
10198956593817CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956593930CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956596016CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956598546CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06
10198956601062CARDINAL HEALTHCardinal Health 200, LLCOES2026-10-06