FDA.report

AVID TruCustom

Primary DI
20809160103934
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
VASL008-03_0001
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OEZCardiovascular procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160103934PackageGS14In Commercial Distribution
10809160103937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916010393420809160103934
1080916010393710809160103937

GMDN Terms

TermDefinition
Single-chamber implantable pacemaker, fixed-rate/demandA battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to the heart typically when the heart beats too slowly (bradycardia) or has other abnormal rhythms (arrhythmias). It may provide constant electrical stimuli to normalize the heartbeat (fixed-rate) and/or provide a stimulus only when electrical activity within the heart is sensed to be abnormal (demand); it is not intended to provide defibrillation therapy.

Sterilization Methods

Method

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
false
Sterilization required before use
false

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