Macroduct® Advanced Supply Kit, w/o Dye, Qty 6
GUDID 03661540304385
For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis
ELITECHGROUP INC.
Sweat-induction iontophoresis system| Primary Device ID | 03661540304385 |
| NIH Device Record Key | e280d98e-4c8b-4317-8311-1744933124fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Macroduct® Advanced Supply Kit, w/o Dye, Qty 6 |
| Version Model Number | SS-268-ND |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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) 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 | |
| Phone | +1 (800) 435 2725 |
| info@elitechgroup.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540304385 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180627
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 | 2021-02-26 |
| Device Publish Date | 2021-02-18 |
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 [Macroduct]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACRODUCT 74288931 1758172 Live/Registered |
ELITECHGROUP INC. 1992-06-26 |
 MACRODUCT 73537998 1379034 Dead/Cancelled |
WESCOR, INC. 1985-05-16 |
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