| Primary Device ID | 00840828193719 |
| NIH Device Record Key | f0bc5c7d-0f24-43f3-af15-e0ca1f779558 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEN4 DIGITAL |
| Version Model Number | 4D360N-Z049288 |
| Catalog Number | 294600 |
| Company DUNS | 796452311 |
| Company Name | CURBELL MEDICAL PRODUCTS, INC. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com | |
| Phone | 1-800-235-7500 |
| mwinter@curbell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840828193719 [Primary] |
| IQA | System, Environmental Control, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-08 |
| Device Publish Date | 2024-12-31 |