100055-102

GUDID 00859144004128

Programmer System

CVRX, INC.

Baroreceptor electrical stimulation system
Primary Device ID00859144004128
NIH Device Record Keye33aa8ee-4e67-44fd-89a2-564d80d6ec03
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9010
Catalog Number100055-102
Company DUNS052373680
Company NameCVRX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859144004128 [Primary]

FDA Product Code

DSRStimulator, Carotid Sinus Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-01-21

Devices Manufactured by CVRX, INC.

00859144004432 - BAROSTIM NEO2019-08-30 BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)
00859144004449 - BAROSTIM Programmer2019-08-30 Model 9010 Programmer System (US Commercial)
00859144004456 - BAROSTIM Lead Repair Kit2019-08-30 Model 5010 Carotid Sinus Lead Repair Kit (US Commercial)
00859144004463 - BAROSTIM NEO2019-08-30 BAROSTIM NEO Model 1036 Carotid Sinus Lead Kit (US Commercial)
00859144004470 - BAROSTIM NEO2019-08-30 BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit
00859144004128 - NA2018-03-29Programmer System
00859144004128 - NA2018-03-29 Programmer System
00859144004203 - NA2018-03-29 Carotid Sinus Lead Repair Kit
00859144004210 - Neo Legacy2018-03-29 Neo Legacy Implantable Pulse Generator

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