| Primary Device ID | 00819989011002 |
| NIH Device Record Key | ac83aa8b-13b1-45ed-b28e-02e25181b4a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CPAP Tubing |
| Version Model Number | CTUB-010-1 |
| Company DUNS | 825179992 |
| Company Name | EXCELERON MEDICAL, 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 | true |
| 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 | 00819989011002 [Primary] |
| GS1 | 10819989011009 [Package] Package: [50 Units] In Commercial Distribution |
| BZO | Set, Tubing And Support, Ventilator (W Harness) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 00819989011163 | CPAP Tubing, 4 ft, single-pack |
| 00819989011149 | CPAP Tubing, 2 ft, single-pack |
| 00819989011125 | CPAP Tubing, 6 ft (Spirit Labeled), single-pack |
| 00819989011101 | CPAP Tubing, 10 ft, single-pack |
| 00819989011088 | CPAP Tubing, 9 ft, single-pack |
| 00819989011064 | CPAP Tubing, 8 ft, single-pack |
| 00819989011040 | CPAP Tubing, 6 ft, single pack |
| 00819989011026 | CPAP Tubing, 6 ft slim-line, single pack |
| 00819989011002 | CPAP Tubing, 1 ft, single pack |
| 10819989011184 | CPAP Tubing, 18 inch, single-pack |