FDA.reportPublic FDA data

respistim R Stimulation Lead, Inline Connector

Primary DI
00857688007438
Brand
respistim R Stimulation Lead, Inline Connector
Company
RESPICARDIA, INC.
Model
3602
Device description
Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector
Published
2021-08-20
Public version status
New
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
P160039006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160039006remede® SystemRespicardia2017-10-06PSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857688007438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857688007438008576880074388576880074380857688007438

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@zoll.com

Regulatory Flags#

DUNS number
027887663
Device count
1
Lot or batch
true
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
00857688007001remede System Implantable Pulse Generator10012018-04-30
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
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
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
00857688007001remede System Implantable Pulse GeneratorRESPICARDIA, INC.PSR2018-04-30
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