| Primary Device ID | 10851629008079 |
| NIH Device Record Key | a3440e3d-4fc2-40ba-b2bc-a7d0144a9bcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAVe II+ |
| Version Model Number | 70110H-US |
| Company DUNS | 606696123 |
| Company Name | Automedx, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com | |
| Phone | 18554286074 |
| info@safeguardmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10851629008079 [Primary] |
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-15 |
| Device Publish Date | 2024-01-06 |
| 90851629008075 | SAVe II+ US Kit with Mask & Headstrap |
| 20851629008076 | SAVe II+ Kit, A&C plugs |
| 10851629008079 | SAVe II+ Kit, US Plug |
| 00851629008072 | SAVe II+ Ventilator |