| Primary Device ID | 05060038512864 |
| NIH Device Record Key | d62832dc-7a92-4f2a-bc87-c03cd9fe9089 |
| Commercial Distribution Discontinuation | 2021-01-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ambu WhiteSensor 4535MECG Electrodes |
| Version Model Number | 4535M |
| Catalog Number | 4535M |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| Device Count | 60 |
| 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 | false |
| 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 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060038510549 [Package] Contains: 05060038512857 Package: [10 Units] Discontinued: 2021-01-31 Not in Commercial Distribution |
| GS1 | 05060038512857 [Package] Package: [5 Units] Discontinued: 2021-01-31 Not in Commercial Distribution |
| GS1 | 05060038512864 [Primary] |
| GS1 | 05707480129393 [Unit of Use] |
| DRX | Electrode, electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-12-16 |
| Device Publish Date | 2016-09-26 |
| 05060038512857 | Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For sh |
| 05060038512864 | Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For sh |