| Primary Device ID | 00850027837635 |
| NIH Device Record Key | 747b1ecb-46b1-48ef-ac65-8707a727bc40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DiamondTemp Generator Adapter |
| Version Model Number | 800818 |
| Catalog Number | 800818 |
| Company DUNS | 844418199 |
| Company Name | ACUTUS MEDICAL, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027837635 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-01 |
| Device Publish Date | 2022-10-24 |
| 00857042007876 | AcQMap to DiamondTemp Generator Adapter |
| 00850027837635 | AcQMap to DiamondTemp Generator Adapter Cable |
| 00850027837253 | AcQMap to DiamondTemp Generator Adapter |