| Primary Device ID | M68904105020 |
| NIH Device Record Key | dd31e91b-e398-41f5-b6bf-ae0ab7cf6d86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hypothermia Prevention Blanket |
| Version Model Number | 02 |
| Catalog Number | 04-105 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68904105020 [Primary] |
| IMD | Pack, Hot Or Cold, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-25 |
| Device Publish Date | 2022-08-17 |
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