| Primary Device ID | 50813150020027 |
| NIH Device Record Key | fd804375-00f2-457b-bb22-61a078505ea9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TenderTrode™ |
| Version Model Number | A10001 |
| Catalog Number | A10001 |
| Company DUNS | 002111896 |
| Company Name | GRAPHIC CONTROLS ACQUISITION CORP |
| Device Count | 3 |
| 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 |
| Phone | 1.800.669.6905 |
| customerservice@vermed.com | |
| Phone | 1.800.669.6905 |
| customerservice@vermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813150020022 [Unit of Use] |
| GS1 | 30813150020023 [Primary] |
| GS1 | 40813150020020 [Package] Contains: 30813150020023 Package: box [25 Units] In Commercial Distribution |
| GS1 | 50813150020027 [Package] Contains: 40813150020020 Package: case [8 Units] In Commercial Distribution |
| 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 | 2017-01-27 |
| 50813150020027 | A10001 |
| 50009336008518 | Infant and Pediatric ECG Electrodes |