| Primary Device ID | 09342451002655 |
| NIH Device Record Key | d46407c9-7a45-452f-9b58-3ec861272d0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Compumedics Somfit |
| Version Model Number | Somfit |
| Catalog Number | 8037-0001-00 |
| Company DUNS | 753750967 |
| Company Name | COMPUMEDICS LIMITED |
| 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 | false |
| 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 | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au | |
| Phone | +61384207386 |
| support@compumedics.com.au |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09342451002655 [Primary] |
| MNR | Ventilatory Effort Recorder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-20 |
| Device Publish Date | 2026-03-12 |
| 09342451002860 | Somfit System Americas (7 electrodes) |
| 09342451002822 | Somfit System Americas |
| 09342451002662 | Somfit Charger |
| 09342451002655 | Somfit Main Unit |