| Primary Device ID | 09342451007063 |
| NIH Device Record Key | 4f5c851b-a269-41c1-9332-830180012997 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Compumedics Somfit D |
| Version Model Number | Somfit D |
| Catalog Number | 9037-0022-00 |
| 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 | 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 | +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 | 09342451007063 [Primary] |
| GS1 | 09342451007124 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 09342451007131 [Package] Package: [50 Units] In Commercial Distribution |
| 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 |
| 09342451002433 - Compumedics Curry | 2026-03-20 CURRY 9 |
| 09342451002655 - Compumedics Somfit | 2026-03-20 Somfit Main Unit |
| 09342451002662 - Compumedics Somfit | 2026-03-20 Somfit Charger |
| 09342451002747 - Compumedics Falcon | 2026-03-20 Falcon HST Main Unit |
| 09342451002754 - Compumedics Falcon | 2026-03-20 Falcon HST Cradle |
| 09342451002785 - Compumedics Falcon | 2026-03-20 Falcon HST System |
| 09342451002822 - Compumedics Somfit | 2026-03-20 Somfit System Americas |
| 09342451002860 - Compumedics Somfit | 2026-03-20 Somfit System Americas (7 electrodes) |