| Primary Device ID | 20885403255646 |
| NIH Device Record Key | 22b5c810-d4c1-4e82-9da2-d05afcbcc307 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SilverTRACE |
| Version Model Number | 91920031 |
| Catalog Number | 91920031 |
| Company DUNS | 367919120 |
| Company Name | Carefusion Finland 320 Oy |
| Device Count | 25 |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885403255649 [Unit of Use] |
| GS1 | 20885403255646 [Package] Contains: 70885403255641 Package: Box [8 Units] In Commercial Distribution |
| GS1 | 70885403255641 [Primary] |
| DRX | Electrode, electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-14 |
| 20885403255646 | SilverTRACE™ ECG Electrodes, 55mm Round, Foam, Wet Gel |
| 20885403253857 | SilverTRACE™ ECG Electrodes, 44x28mm Rectangular, Foam, Banana Plug, Wet Gel |
| 20885403253840 | SilverTRACE™ ECG Electrodes, 44x32mm Rectangular, Foam, Wet Gel |
| 20885403253574 | SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel |
| 20885403253567 | SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel |
| 20885403253192 | SilverTRACE™ ECG Electrodes, 55mm Round, Microporous Tape, Wet Gel |
| 20885403252782 | SilverTRACE™ ECG Electrodes, 50mm Round, Vinyl Tape, Solid Gel |
| 20885403252775 | SilverTRACE™ ECG Electrodes, 40mm Round, Cloth, Solid Gel |
| 20885403252768 | SilverTRACE™ ECG Electrodes, 55mm Round, Foam, Wet Gel |
| 20885403252751 | SilverTRACE™ ECG Electrodes, 35x41mm Oval, Foam, Solid Gel |
| 20885403252317 | SilverTRACE™ ECG Electrodes, 50x38mm Oval, Foam, Wet Gel |
| 20885403252300 | SilverTRACE™ ECG Electrodes, 50x38mm Oval, Foam, Wet Gel |
| 20885403251945 | SilverTRACE™ ECG Electrodes, 44x32mm Rectangular, Foam, Radiolucent, Wet Gel |
| 20885403251938 | SilverTRACE™ ECG Electrodes, 50mm Round, Foam, Wet Gel |
| 20885403251921 | SilverTRACE™ ECG Electrodes, 44x32mm Rectangular, Foam, Wet Gel |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SILVERTRACE 74224229 1947107 Live/Registered |
CAREFUSION 2201, INC. 1991-11-22 |