Primary Device ID | 08806094458220 |
NIH Device Record Key | 221f2499-59b8-455f-b851-d03d97531e61 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | S4343-AWM |
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 |
08806094948233 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2023-10-31 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |
08806094948240 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2023-10-31 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |
08806094744934 - NA | 2022-10-28 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph |
08806094458213 - NA | 2022-05-12 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph |
08806094458220 - NA | 2022-05-12Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that 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. |
08806094458220 - NA | 2022-05-12 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph |
08806088351872 - NA | 2021-10-11 The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai |
08806088351889 - NA | 2021-10-11 The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/tra |
08806088520971 - NA | 2021-10-11 The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualifie |