| Primary Device ID | 00816472021913 |
| NIH Device Record Key | afb3e601-af84-47b7-88c5-8798321e0ad2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EcoLite, pediatric, medium concentration oxygen mask |
| Version Model Number | 11906100 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
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