| Primary Device ID | 00813830022834 |
| NIH Device Record Key | 9d502329-27cf-4924-afda-a56bc0ca106c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Portable O2 System - Manual Resuscitator |
| Version Model Number | 38006 |
| Catalog Number | 38006 |
| Company DUNS | 088302096 |
| Company Name | ACCUTRON, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813830022834 [Primary] |
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-02 |
| Device Publish Date | 2023-09-22 |
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