| Primary Device ID | 00819989011576 |
| NIH Device Record Key | 8f8a7833-ce9a-452f-aa7d-837e083714ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermalite Heated CPAP Tube |
| Version Model Number | CTUB-06H15DS |
| Company DUNS | 825179992 |
| Company Name | EXCELERON MEDICAL, 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819989011576 [Primary] |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-20 |
| Device Publish Date | 2025-01-10 |
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| 10819989011184 - CPAP Tubing | 2021-06-01 CPAP Tubing, 18 inch, single-pack |
| 00819989011002 - CPAP Tubing | 2020-10-02 CPAP Tubing, 1 ft, single pack |
| 00819989014904 - BVF22 Bacteria Filter | 2020-10-02 BVF22 Bacteria Filter |
| 00812970012002 - Nuwave | 2020-10-01 NUWAVE Generator |
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