Primary Device ID | 00857688007070 |
NIH Device Record Key | 2f43eed2-5871-42b2-bb6f-cad556c7e3cf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | respistim R Stimulation Lead |
Version Model Number | 3103 |
Company DUNS | 027887663 |
Company Name | RESPICARDIA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +19525404471 |
mlynn@respicardia.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857688007070 [Primary] |
PSR | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2018-04-30 |
00857688007070 | Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil |
00857688007063 | Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil di |