remede EL-X System Implantable Pulse Generator Inline Connector

GUDID 00857688007407

remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header

RESPICARDIA, INC.

Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit Transvenous phrenic nerve electrical stimulation control unit
Primary Device ID00857688007407
NIH Device Record Keyec6a626c-ef90-489d-acbb-30059b0d10fe
Commercial Distribution StatusIn Commercial Distribution
Brand Nameremede EL-X System Implantable Pulse Generator Inline Connector
Version Model Number1600
Company DUNS027887663
Company NameRESPICARDIA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com
Phone+19525404471
Emailmlynn@zoll.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857688007407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

Devices Manufactured by RESPICARDIA, INC.

00857688007391 - remede EL System Implantable Pulse Generator IS-12021-08-30 remede EL System, implantable pulse generator for phrenic nerve stimulation, IS-1 header
00857688007407 - remede EL-X System Implantable Pulse Generator Inline Connector2021-08-30remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header
00857688007407 - remede EL-X System Implantable Pulse Generator Inline Connector2021-08-30 remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header
00857688007414 - remede EL/EL-X External Pulse Generator2021-08-30 remede EL/EL-X external pulse generator
00857688007421 - Lead Test Adaptor, remede EL-X2021-08-30 Lead Test Adaptor, remede EL-X, for use with Inline Connector Leads
00857688007438 - respistim R Stimulation Lead, Inline Connector2021-08-30 Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral
00857688007445 - respistim R Stimulation Lead, Inline Connector2021-08-30 Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spi
00857688007452 - respistim R Stimulation Lead, Inline Connector2021-08-30 Respiratory stimulation lead; respistim R, 50cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral
00857688007469 - respistim R Stimulation Lead, Inline Connector2021-08-30 Respiratory stimulation lead. respistim R, 50 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spi
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