| Primary Device ID | 10858409005181 |
| NIH Device Record Key | 1cca9bba-4191-48a2-b6d0-5833ad2f1230 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tracheostomy HME |
| Version Model Number | MC-785 |
| Catalog Number | MC-785 |
| Company DUNS | 154454730 |
| Company Name | Medicomp |
| 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 | false |
| 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 | 00858409005184 [Primary] |
| GS1 | 10858409005181 [Package] Contains: 00858409005184 Package: case [50 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-15 |
| 10858409005631 - Pediatric HME | 2020-08-14 |
| 10858409005624 - Large Manual Percussor Cup; 89mm | 2020-04-30 Large Manual Percussor Cup; 89mm |
| 10858409005280 - C02 Sampling Adapter | 2019-11-27 |
| 10858409005372 - Washington Tee | 2019-11-27 |
| 10858409005389 - C02 Sampling Adapter with Cap | 2019-11-27 |
| 00858409005009 - Adult Bacterial/Viral Filter | 2019-01-23 |
| 10858409005013 - Infant Bacterial/Viral Filter | 2019-01-23 |
| 00858409005023 - Nebulizer Bacteria Filter | 2019-01-23 |