| Primary Device ID | 00860008259219 |
| NIH Device Record Key | f3d9624f-a305-4ef8-bb82-c57613608c0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrogel Adhesive |
| Version Model Number | B08 |
| Company DUNS | 013311479 |
| Company Name | VIVALNK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008259219 [Primary] |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-21 |
| Device Publish Date | 2022-02-11 |
| 00865064000188 | The silicon patch is a small, thin layer of soft silicon used for the adherence of specific sens |
| 00865064000195 | Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives |
| 00860008259219 | Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives |
| 00860008259202 | Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives |
| 00860008259226 | Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives |