| Primary Device ID | 00840828114219 |
| NIH Device Record Key | c8cf94c8-28a1-4584-8bdd-7044a918439c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESPONDER 5, STANDARD |
| Version Model Number | 4D412N-100033A |
| Catalog Number | 2684 |
| 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 | 1-800-235-7500 |
| mwinter@curbell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840828114219 [Primary] |
| IQA | System, Environmental Control, Powered |
| 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 | 2016-09-24 |
| 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 |