| Primary Device ID | 00840828194242 | 
| NIH Device Record Key | 6572207a-eae0-495e-9ecd-fc2bd6439530 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | REGO 1.1,PID,WT,PN,TL,FD,14' | 
| Version Model Number | PD11-100400000E | 
| Catalog Number | 27855 | 
| 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 | false | 
| 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 | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840828194242 [Primary] | 
| ILQ | System, Communication, 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 | 2025-03-07 | 
| Device Publish Date | 2025-02-27 |