| Primary Device ID | 03661540303418 |
| NIH Device Record Key | 853c9eea-c9fc-48ed-bdd8-5b000ffb5fd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nanoduct Neonatal Sweat Analysis System |
| Version Model Number | Nanoduct Sys 1030 |
| Company DUNS | 052423787 |
| Company Name | ELITECHGROUP INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540303418 [Primary] |
| KTB | Device, Iontophoresis, Specific Uses |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-22 |
| Device Publish Date | 2016-09-24 |
| 03661540300400 - Macroduct Advanced Sweat Collection System | 2025-03-07 The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for s |
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| 03661540300219 - Monosed® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300257 - Excyte® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300264 - Excyte® ESR Vacuum Tube, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |