Nanoduct® Neg (-) Black Holder, Qty 1
GUDID 03661540302015
For use with Neonatal Sweat Analysis System to attach electrodes and sensor cells used to induce and collect sweat for diagnosis of Cystic Fibrosis.
ELITECHGROUP INC.
Sweat-induction iontophoresis device/conductivity analyser| Primary Device ID | 03661540302015 |
| NIH Device Record Key | 792a74c9-db83-403e-8b0c-c22d6cef60ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nanoduct® Neg (-) Black Holder, Qty 1 |
| Version Model Number | RP-358 |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com | |
| Phone | 1-800-453-2725 |
| service_ebs@elitechgroup.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540302015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K010031
FDA Product Code
| KTB | Device, Iontophoresis, Specific Uses |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-01 |
| Device Publish Date | 2021-02-19 |
Devices Manufactured by ELITECHGROUP INC.
| 03661540300035 - Microsed-System® Automated ESR Analyzer | 2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de |
| 03661540300042 - Mix-Rate® X20 Automated ESR Analyzer | 2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de |
| 03661540300202 - 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 |
| 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 |
| 03661540300271 - 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 |
Trademark Results [Nanoduct]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NANODUCT 76262460 2633198 Live/Registered |
ELITECHGROUP INC. 2001-05-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.