| Primary Device ID | 18906035283908 |
| NIH Device Record Key | 4871057a-0b7e-4e7e-a847-59361cdcc036 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambu WhiteSensor |
| Version Model Number | WS-00-S/4 |
| Company DUNS | 677425215 |
| Company Name | MEDICO ELECTRODES INTERNATIONAL LIMITED |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08906035283901 [Primary] |
| GS1 | 18906035283908 [Package] Contains: 08906035283901 Package: [15 Units] In Commercial Distribution |
| GS1 | 28906035283905 [Package] Package: [10 Units] In Commercial Distribution |
| GS1 | 38906035283902 [Package] Contains: 28906035283905 Package: [6 Units] In Commercial Distribution |
| GS1 | 48906035283909 [Unit of Use] |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-28 |
| Device Publish Date | 2020-08-20 |
| 18906035283991 | Electrocardiographic electrode, single use |
| 18906035283984 | Electrocardiographic electrode, single use |
| 18906035283977 | Electrocardiographic electrode, single use |
| 18906035283960 | Electrocardiographic electrode, single use |
| 18906035283946 | Electrocardiographic electrode, single use |
| 18906035283939 | Electrocardiographic electrode, single use |
| 18906035283922 | Electrocardiographic electrode, single use |
| 18906035283915 | Electrocardiographic electrode, single use |
| 18906035283908 | Electrocardiographic electrode, single use |
| 18906035283892 | Electrocardiographic electrode, single use |
| 18906035283885 | Electrocardiographic electrode, single use |
| 18906035283861 | Electrocardiographic electrode, single use |
| 18906035283403 | Electrode skin abrasion pad |
| 18906035283397 | Electrocardiograph electrodes, single use |
| 18906035283281 | Electrocardiographic electrode, single use |
| 18906035283274 | Electrocardiographic electrode, single use |
| 18906035281331 | Electrocardiographic electrode, single use |
| 18906035283250 | Electrocardiographic electrode, single use |
| 18906035283243 | Electrocardiographic electrode, single use |
| 18906035281348 | Electrocardiographic electrode, single use |
| 18906035283175 | Electrocardiographic electrode, single use |
| 18906035283168 | Electrocardiographic electrode, single use |
| 18906035282932 | Electrocardiographic electrode, single use |
| 18906035283144 | Electrocardiographic electrode, single use |
| 18906035283120 | Electrocardiographic electrode, single use |
| 18906035283106 | Electrocardiographic electrode, single use |
| 18906035283090 | Electrocardiographic electrode, single use |
| 18906035283083 | Electrocardiographic electrode, single use |
| 18906035283076 | Electrocardiographic electrode, single use |
| 18906035283069 | Electrocardiographic electrode, single use |
| 18906035283052 | Electrocardiographic electrode, single use |
| 18906035283045 | Electrocardiographic electrode, single use |
| 18906035283021 | Electrocardiographic electrode, single use |
| 18906035283014 | Electrocardiographic electrode, single use |
| 18906035282987 | Electrocardiographic electrode, single use |
| 18906035282963 | Electrocardiographic electrode, single use |
| 18906035282956 | Electrocardiographic electrode, single use |
| 18906035282949 | Electrocardiographic electrode, single use |
| 18906035282918 | Electrocardiographic electrode, single use |
| 18906035282901 | Electrocardiographic electrode, single use |
| 18906035282895 | Electrocardiographic electrode, single use |
| 18906035282888 | Electrocardiographic electrode, single use |
| 28906035282694 | Electrocardiographic electrode, single use |
| 18906035282925 | Electrocardiographic electrode, single use |
| 18906035281584 | Electrocardiographic electrode, single use |
| 18906035283366 | Electrocardiographic electrode, single use |
| 18906035283335 | Electrocardiograph electrode, single use |
| 18906035283342 | Electrocardiographic electrode, single use |
| 18906035283373 | Electrocardiographic electrode, single use |
| 18906035281171 | Electrocardiographic electrode, single use |