| Primary Device ID | 00840828177467 |
| NIH Device Record Key | 1e57ddba-172b-4d8f-84b9-c75d2f747ea6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEN4 Direct Access |
| Version Model Number | 5C430U-Z30200029 |
| Catalog Number | 25767 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840828177467 [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 | 2020-03-09 |
| Device Publish Date | 2020-02-28 |
| 00840828166713 | GEN4 DIRECT ACCESS |
| 00840828172844 | GEN4 DIRECT ACCESS |
| 00840828172875 | GEN4 DIRECT ACCESS |
| 00840828172905 | GEN4 DIRECT ACCESS |
| 00840828172967 | GEN4 DIRECT ACCESS |
| 00840828172936 | GEN4 DIRECT ACCESS |
| 00840828160155 | GEN4 DIRECT ACCESS |
| 00840828172981 | GEN4 DIRECT ACCESS |
| 00840828173391 | GEN4 DIRECT ACCESS |
| 00840828173513 | GEN4 DIRECT ACCESS |
| 00840828173483 | GEN4 DIRECT ACCESS |
| 00840828147491 | GEN4 DIRECT ACCESS |
| 00840828173599 | GEN4 DIRECT ACCESS |
| 00840828173582 | GEN4 DIRECT ACCESS |
| 00840828173575 | GEN4 DIRECT ACCESS |
| 00840828174466 | GEN4 DIRECT ACCESS |
| 00840828175234 | GEN4 DIRECT ACCESS |
| 00840828174909 | GEN4 DIRECT ACCESS |
| 00840828176415 | GEN4 DIRECT ACCESS |
| 00840828143363 | GEN4 Direct Access |
| 00840828141420 | GEN4 Direct Access |
| 00840828141406 | GEN4 Direct Access |
| 00840828141390 | GEN4 Direct Access |
| 00840828141383 | GEN4 Direct Access |
| 00840828141376 | GEN4 Direct Access |
| 00840828177610 | GEN4 Direct Access |
| 00840828177580 | GEN4 Direct Access |
| 00840828177504 | GEN4 Direct Access |
| 00840828177498 | GEN4 Direct Access |
| 00840828177467 | GEN4 Direct Access |
| 00840828177450 | GEN4 Direct Access |
| 00840828177443 | GEN4 Direct Access |
| 00840828179379 | GEN4 Direct Access |
| 00840828176675 | GEN4 Direct Access |
| 00840828176644 | GEN4 Direct Access |
| 00840828174060 | GEN4 DIRECT ACCESS |
| 00840828174053 | GEN4 DIRECT ACCESS |
| 00840828174015 | GEN4 DIRECT ACCESS |
| 00840828173803 | GEN4 DIRECT ACCESS |
| 00840828173773 | GEN4 DIRECT ACCESS |
| 00840828173292 | GEN4 DIRECT ACCESS |
| 00840828173186 | GEN4 DIRECT ACCESS |
| 00840828173148 | GEN4 DIRECT ACCESS |
| 00840828165112 | GEN4 DIRECT ACCESS |
| 00840828165037 | GEN4 DIRECT ACCESS |
| 00840828164900 | GEN4 DIRECT ACCESS |
| 00840828164894 | GEN4 DIRECT ACCESS |
| 00840828164849 | GEN4 DIRECT ACCESS |
| 00840828164542 | GEN4 DIRECT ACCESS |
| 00840828164443 | GEN4 DIRECT ACCESS |