| Primary Device ID | 00816472021814 |
| NIH Device Record Key | bfdb87eb-fc50-4c43-b460-568aca70092b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silente Eco, adult, adjustable venturi mask kit with universal connector tube |
| Version Model Number | 11376100 |
| 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 | false |
| 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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