| Primary Device ID | J014660953350 |
| NIH Device Record Key | d4af5b19-0b0d-4c47-ae9c-4f77697a7e14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Venus Bulk Flow ONE |
| Version Model Number | 66095335 |
| Catalog Number | 66095335 |
| Company DUNS | 315666321 |
| Company Name | Heraeus Kulzer GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J014660953350 [Primary] |
| EBF | Material, tooth shade, resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-09 |
| Device Publish Date | 2022-12-01 |
| J014660953350 | Venus Bulk Flow ONE Value-Kit Syringe |
| J014660947240 | Venus Bulk Flow ONE PLT Refill |
| J014660947230 | Venus Bulk Flow ONE Syringe Refill |
| J014660982790 | PROC Venus Bulk Flow ONE Kit 1x2G SYR |