| Primary Device ID | G298153187220013 |
| NIH Device Record Key | ebcca630-0684-431c-bdf0-6455ed25914d |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 1531872200-1 |
| Catalog Number | 15318722001 |
| Company DUNS | 119290896 |
| Company Name | Control Devices, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G298153187220010 [Primary] |
| HIBCC | G298153187220013 [Package] Contains: G298153187220010 Package: Box [50 Units] In Commercial Distribution |
| CAN | Regulator, Pressure, Gas Cylinder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-05 |
| Device Publish Date | 2024-07-26 |
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| 00810051631227 - Control Devices | 2025-06-10 CGA 280 Regulator, 70:30 Heliox, 50 psig, Barbed Outlet, Brown Body |
| 00810051631241 - Control Devices | 2025-06-10 CGA 280 Regulator, 70:30 Heliox, 50 psig, Barbed Outlet, Brown Body, DISS 1180 Auxiliary Port |
| 00810051631258 - Control Devices | 2025-06-10 CGA 280 Regulator, 80:20 Heliox, 50 psig, Barbed Outlet, Brown Body, DISS 1180 Auxiliary Port |
| 00810051631333 - Control Devices | 2025-06-10 CGA 540 Oxygen Regulator, 50 psig, DISS 1240 Outlet |
| 00810051631340 - Control Devices | 2025-06-10 CGA 540 Oxygen Regulator, 50 psig, DISS 1240 Outlet |