| Primary Device ID | 08806088582412 |
| NIH Device Record Key | 75a102b0-35a6-41b5-9853-a1b4271f196b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | GM85 |
| Company DUNS | 687967554 |
| Company Name | Samsung Electronics Co., Ltd. |
| 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 | false |
| 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 |
| 08806088565231 - NA | 2026-03-17 The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/tra |
| 08806088582412 - NA | 2026-03-17The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. |
| 08806088582412 - NA | 2026-03-17 The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai |
| 08806094936872 - Samsung Sleep Apnea Feature (Wear OS) | 2025-03-04 The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung |
| 08806094936889 - Samsung Sleep Apnea Feature (Android OS) | 2025-03-04 The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung |
| 08806095896144 - NA | 2024-12-04 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph |
| 08806095799636 - NA | 2024-10-28 The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai |
| 08806095799643 - NA | 2024-10-28 The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai |
| 08806094940756 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2024-07-15 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |