| Primary Device ID | 00840828194020 | 
| NIH Device Record Key | ebef3dfe-fc62-4d8f-a401-7d4255488737 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | RESPONDER 5, STANDARD | 
| Version Model Number | 4D41BN-764403A | 
| Catalog Number | 29688 | 
| 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 | 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 | |
| Phone | 18002357500 | 
| mwinter@curbell.com | |
| Phone | 18002357500 | 
| mwinter@curbell.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840828194020 [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 | 2025-02-24 | 
| Device Publish Date | 2025-02-14 | 
| 00840828156615 | RESPONDER 5, STANDARD | 
| 00840828154321 | 0900,S,10,NV,N,TU,TD,UL,NO ENTERTAINMENT | 
| 00840828145077 | RESPONDER 5, STANDARD | 
| 00840828138260 | RESPONDER 5, STANDARD | 
| 00840828136266 | RESPONDER 5, STANDARD | 
| 00840828135740 | RESPONDER 5, STANDARD | 
| 00840828135672 | RESPONDER 5, STANDARD | 
| 00840828134576 | RESPONDER 5, STANDARD | 
| 00840828134224 | RESPONDER 5, STANDARD | 
| 00840828133630 | RESPONDER 5, STANDARD | 
| 00840828127677 | RESPONDER 5, STANDARD | 
| 00840828119764 | RESPONDER 5, STANDARD | 
| 00840828119450 | RESPONDER 5, STANDARD | 
| 00840828114226 | RESPONDER 5, STANDARD | 
| 00840828114219 | RESPONDER 5, STANDARD | 
| 00840828114202 | RESPONDER 5, STANDARD | 
| 00840828114196 | RESPONDER 5, STANDARD | 
| 00840828114134 | RESPONDER 5, STANDARD | 
| 00840828114127 | RESPONDER 5, STANDARD | 
| 00840828114110 | RESPONDER 5, STANDARD | 
| 00840828114103 | RESPONDER 5, STANDARD | 
| 00840828114097 | RESPONDER 5, STANDARD | 
| 00840828114080 | RESPONDER 5, STANDARD | 
| 00840828114073 | RESPONDER 5, STANDARD | 
| 00840828114066 | RESPONDER 5, STANDARD | 
| 00840828183024 | RESPONDER 5, STANDARD | 
| 00840828184595 | RESPONDER 5, STANDARD | 
| 00840828189927 | RESPONDER 5, STANDARD | 
| 00840828193832 | 4D410U-700031A | 
| 00840828194099 | 4D41BN-700003A | 
| 00840828194068 | 4D41BN-764393A | 
| 00840828194044 | 4D41BN-700393A | 
| 00840828194037 | 4D41BN-700403A | 
| 00840828194020 | 4D41BN-764403A |