| Primary Device ID | 20889483231682 |
| NIH Device Record Key | 3caead4c-4207-47e1-88eb-e8cfd36ea6a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Medical Hyperinflation System |
| Version Model Number | 0413 |
| Catalog Number | 0413 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| 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 | 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 | |
| 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 | |
| Phone | 1-800-433-2797 |
| info@sun-med.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078001666 [Previous] |
| GS1 | 10889483231685 [Primary] |
| GS1 | 20889483231682 [Package] Contains: 10889483231685 Package: [20 Units] In Commercial Distribution |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-01 |
| Device Publish Date | 2025-11-10 |
| 20889483231682 | AirLife™ Hyperinflation System, Transport Elbow, 8' Oxygen Tubing with Threaded Nut |
| 20889483229894 | AirLife™ Hyperinflation System, Hyperinflation Elbow, 7' O2 and Pressure Lines |