| Primary Device ID | 20818524020138 |
| NIH Device Record Key | 67c8d385-9f18-4fce-acc8-fb305ed36018 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROOT LABS - VPS |
| Version Model Number | RL760 |
| Catalog Number | RL760 |
| Company DUNS | 030479000 |
| Company Name | CROWN DELTA CORPORATION |
| Device Count | 1 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818524020134 [Primary] |
| GS1 | 10818524020131 [Package] Contains: 00818524020134 Package: KIT [4 Units] In Commercial Distribution |
| GS1 | 20818524020138 [Package] Contains: 10818524020131 Package: CASE [10 Units] In Commercial Distribution |
| ELW | Material, Impression |
| 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 | 2017-05-01 |
| 20818524020138 | ROOT LABS REGULAR BODY FAST/SET HP - 50 ML CARTRIDGE |
| 20818524020121 | ROOT LABS REGULAR BODY REG/SET HP - 50 ML CARTRIDGE |
| 20818524020114 | ROOT LABS INJECTION FAST/SET HP - 50 ML CARTRIDGE |
| 20818524020107 | ROOT LABS INJECTION REG/SET HP |