| Primary Device ID | 00840117333024 |
| NIH Device Record Key | 693105f0-a937-4c66-b244-b6f3061251fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XeroBurn Sterile Burn Dressing Blanket 60"x 70" |
| Version Model Number | 1338 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117333024 [Package] Contains: 00840117333031 Package: MC Master [1 Units] In Commercial Distribution |
| GS1 | 00840117333031 [Primary] |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-02 |
| Device Publish Date | 2024-03-25 |
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| 00840117338135 - Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve | 2024-08-02 Standard: Dot -3AL, Nominal Working Pressure; 139 (BAR), Hydraulic Test Pressure: 232 (BAR), Material: Aluminum alloy 6061, Actu |
| 00840117334359 - Greenline Cruiser Wheelchair 16" with Foot Rest | 2024-08-01 |