| Primary Device ID | 10889483228692 |
| NIH Device Record Key | 99aef4e4-8a43-431f-a323-6341802606cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SavEar™ |
| Version Model Number | RT-6100 |
| Catalog Number | RT-6100 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078013157 [Previous] |
| GS1 | 10889483228692 [Primary] |
| GS1 | 20889483228699 [Package] Package: Box [40 Units] In Commercial Distribution |
| JAY | Support, Breathing Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-23 |
| Device Publish Date | 2025-12-15 |
| 10889483222317 - UniHEART™ | 2025-12-23 UniHEART™ Low Flow Continuous Nebulizer, Adult Mask, 7' Tubing with Threaded Nut |
| 10889483222324 - HEART™ | 2025-12-23 HEART™ Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing, 10cc Syringe |
| 10889483223703 - HEART™ | 2025-12-23 HEART™ Continuous Nebulizer |
| 10889483223710 - HEART™ | 2025-12-23 HEART™ Direct Connect Continuous Nebulizer, HEART™ Only |
| 10889483223734 - HEART™ | 2025-12-23 HEART™ Direct Connect Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing |
| 10889483223758 - HEART™ | 2025-12-23 HEART™ Direct Connect Continuous Nebulizer, Super Spike Mask, 8' Corrugated Tubing |
| 10889483223765 - HEART™ | 2025-12-23 HEART™ Direct Connect Continuous Nebulizer, Pediatric Aerosol Mask, 8' Corrugated Tubing |
| 10889483223772 - HEART™ | 2025-12-23 HEART™ Direct Connect Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing |