FDA.reportPublic FDA data

remede System Implantable Pulse Generator

Primary DI
00857688007001
Brand
remede System Implantable Pulse Generator
Company
RESPICARDIA, INC.
Model
1001
Device description
remede System, implantable pulse generator for phrenic nerve stimulation
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSRImplanted Phrenic Nerve Stimulator For Central Sleep ApneaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160039000remede® SystemRespicardia2017-10-06PSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857688007001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857688007001008576880070018576880070010857688007001

GMDN Terms#

Term, Definition table
TermDefinition
Transvenous phrenic nerve electrical stimulation control unitAn electrically-powered device designed to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning. It consists of a pulse generator and a graphical user interface to adjust settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+19525404471mlynn@respicardia.com
+1-952-540-4471mlynn@zoll.com

Regulatory Flags#

DUNS number
027887663
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857688007384respistim LQS Stimulation Lead, Additional Proximal Tubing41652020-10-09
00857688007063respistim R Stimulation Lead31022018-04-30
00857688007070respistim R Stimulation Lead31032018-04-30
00857688007230respistim LQS Stimulation Lead40652018-04-30
00857688007278Respiguide Delivery System7120-S2018-04-30
00857688007315remede System Programmer1002A2018-04-30
00857688007322remede System Programming Wand1004A2018-04-30
00857688007339remede System Flexible Programming Wand1004A-F2018-04-30
00857688007346remede System External Pulse Generator10062018-04-30
00857688007391remede EL System Implantable Pulse Generator IS-111002021-08-20
00857688007407remede EL-X System Implantable Pulse Generator Inline Connector16002021-08-20
00857688007414remede EL/EL-X External Pulse Generator1006A2021-08-20
00857688007421Lead Test Adaptor, remede EL-X10072021-08-20
00857688007438respistim R Stimulation Lead, Inline Connector36022021-08-20
00857688007445respistim R Stimulation Lead, Inline Connector36032021-08-20
00857688007452respistim R Stimulation Lead, Inline Connector36522021-08-20
00857688007469respistim R Stimulation Lead, Inline Connector36532021-08-20
00857688007483respistim LQS Stimulation Lead, Inline Connector46652021-08-20
00857688007490respistim LQS Stimulation Lead, Inline Connector46852021-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857688007391remede EL System Implantable Pulse Generator IS-1RESPICARDIA, INC.PSR2021-08-20
00857688007407remede EL-X System Implantable Pulse Generator Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007414remede EL/EL-X External Pulse GeneratorRESPICARDIA, INC.PSR2021-08-20
00857688007421Lead Test Adaptor, remede EL-XRESPICARDIA, INC.PSR2021-08-20
00857688007438respistim R Stimulation Lead, Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007445respistim R Stimulation Lead, Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007452respistim R Stimulation Lead, Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007469respistim R Stimulation Lead, Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007483respistim LQS Stimulation Lead, Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007490respistim LQS Stimulation Lead, Inline ConnectorRESPICARDIA, INC.PSR2021-08-20
00857688007384respistim LQS Stimulation Lead, Additional Proximal TubingRESPICARDIA, INC.PSR2020-10-09
00857688007063respistim R Stimulation LeadRESPICARDIA, INC.PSR2018-04-30
00857688007070respistim R Stimulation LeadRESPICARDIA, INC.PSR2018-04-30
00857688007230respistim LQS Stimulation LeadRESPICARDIA, INC.PSR2018-04-30
00857688007315remede System ProgrammerRESPICARDIA, INC.PSR2018-04-30
00857688007322remede System Programming WandRESPICARDIA, INC.PSR2018-04-30
00857688007339remede System Flexible Programming WandRESPICARDIA, INC.PSR2018-04-30
00857688007346remede System External Pulse GeneratorRESPICARDIA, INC.PSR2018-04-30