| Primary Device ID | 00850252006066 |
| NIH Device Record Key | a09cbc0c-61e1-4e02-bf61-e9b32713de0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avery Breathing Pacemaker System |
| Version Model Number | NeurostimulatorTransmitter Digital |
| Catalog Number | Spirit |
| Company DUNS | 064726441 |
| Company Name | Avery Biomedical Devices Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 631-864-1600 |
| info@averybiomedical.com |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850252006066 [Primary] |
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2019-11-08 |
| 00850252006059 | Transtelephonic Monitor |
| 00850252006042 | (902A) 2.0 m Lead Length |
| 00850252006035 | (902A) 1.0 m Lead Length |
| 00850252006028 | Neurostimulator Electrode Implant |
| 00850252006011 | Neurostimulator Receiver Implant |
| 00850252006004 | Neurostimulator Transmitter |
| 00850252006066 | Digital Transmitter for the Avery Breathing Pacemaker System |