| Primary Device ID | M6892500301010 |
| NIH Device Record Key | e19ec09b-ff98-4b5b-8caf-41ff3d8da805 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAVeII+ Starter Bundle, 3-Patient – Basic |
| Version Model Number | 01 |
| Catalog Number | 25-003-01 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com | |
| Phone | 855-428-6074 |
| fulfillment@combatmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M6892500301010 [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 | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
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