| Primary Device ID | 00848530081942 |
| NIH Device Record Key | de506942-cbbf-4517-896c-8d40e6110eb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flex O2 Bag |
| Version Model Number | CSBM6Flex |
| Catalog Number | CSBM6Flex |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530081942 [Primary] |
| GS1 | 10848530081949 [Package] Package: [50 Units] In Commercial Distribution |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-07-31 |
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