| Primary Device ID | M689M40105010 |
| NIH Device Record Key | 057eed04-e201-482f-bf52-1e1667bae8c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safeguard Medical |
| Version Model Number | 01 |
| Catalog Number | M40105 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, 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 | 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 | M689M40105010 [Primary] |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-27 |
| Device Publish Date | 2023-04-19 |
| M689M4010510020 | Ruggedized Patient Breathing Circuit, case of 10 |
| M689M40105010 | Ruggedized Patient Breathing Circuit, each |