FDA.reportPublic FDA data

VIDA

Primary DI
00801741090974
Brand
VIDA
Company
Bard Peripheral Vascular, Inc.
Model
VDA100262
Catalog number
VDA100262
Device description
VIDA™ PTV Dilatation Catheter, 26mm x 2cm, 100cm catheter
Published
2016-09-16
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
OMZPulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741090974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741090974008017410909748017410909740801741090974

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
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
00801741000331UltraClip® II Breast Tissue Marker8610178610172015-09-25
00801741032004SenoMark® Ultra Breast Tissue MarkerSMEC7CSMEC7C2015-10-02
00801741032011SenoMark® Ultra Breast Tissue MarkerSMEC7RSMEC7R2015-10-02
00801741032028SenoMark® Ultra Breast Tissue MarkerSMEC10CSMEC10C2015-10-01
00801741032035SenoMark® Ultra Breast Tissue MarkerSMEC10RSMEC10R2015-10-01
00801741032042SenoMark® Ultra Breast Tissue MarkerSMEC12CSMEC12C2015-10-01
00801741032059SenoMark® Ultra Breast Tissue MarkerSMEC12RSMEC12R2015-10-02
00801741032066SenoMark® Ultra Breast Tissue MarkerSMMA11CSMMA11C2015-10-01
00801741032073SenoMark® Ultra Breast Tissue MarkerSMMA11RSMMA11R2015-10-01
00801741032080SenoMark® Ultra Breast Tissue MarkerSMAT9CSMAT9C2015-10-02
00801741032097SenoMark® Ultra Breast Tissue MarkerSMAT9RSMAT9R2015-10-02
00801741032103SenoMark® Ultra Breast Tissue MarkerSMAT12CSMAT12C2015-10-01
00801741032110SenoMark® Ultra Breast Tissue MarkerSMAT12RSMAT12R2015-10-01
00801741032127SenoMark® Ultra Breast Tissue MarkerSMEV9CSMEV9C2015-10-02
00801741032134SenoMark® Ultra Breast Tissue MarkerSMEV9RSMEV9R2015-10-02
00801741032219UltraClip® Dual Trigger Breast Tissue Marker862017D862017D2015-09-25
00801741032226UltraClip® Dual Trigger Breast Tissue Marker862017DL862017DL2015-09-25
00801741032233UltraClip® Dual Trigger Breast Tissue Marker863017D863017D2015-09-25
00801741032240UltraClip® Dual Trigger Breast Tissue Marker863017DL863017DL2015-09-25
00801741032257UltraClip® Dual Trigger Breast Tissue Marker864017D864017D2015-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741090790VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090806VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090813VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090820VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090837VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090844VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090851VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090868VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090875VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090882VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090899VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090905VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090912VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090929VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090936VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090943VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090950VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090967VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
00801741090981VIDABard Peripheral Vascular, Inc.OMZ2016-09-16
0069010319181320MM X 4CM X 130CM EDWARDS BALLOON CATHETEREdwards Lifesciences LLCOMZ2015-12-01
0069010319182023MM X 4CM X 130CM EDWARDS BALLOON CATHETEREdwards Lifesciences LLCOMZ2015-12-01
0069010319345925MM X 4CM X 130CM EDWARDS BALLOON CATHETEREdwards Lifesciences LLCOMZ2015-12-01
00690103194333EDWARDS BALLOON CATHETEREdwards Lifesciences LLCOMZ2015-12-01