| Primary Device ID | 00813830022049 |
| NIH Device Record Key | 982cc140-b9f1-4bcb-9119-f820c5c76b7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surface Q/C O2 Outlet |
| Version Model Number | 34077 |
| Catalog Number | 34077 |
| Company DUNS | 088302096 |
| Company Name | ACCUTRON, INC. |
| 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | 1-800-483-7433 |
| regulatoryaffairs@hu-friedy.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813830022049 [Primary] |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline |
| BYX | Tubing, Pressure And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-02 |
| Device Publish Date | 2023-09-22 |