| Primary Device ID | 00866035000343 |
| NIH Device Record Key | e0f36bb1-17fc-4723-8080-961f7fd7d25e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shikani HME |
| Version Model Number | S-HME |
| Company DUNS | 063502758 |
| Company Name | Airway Company, The |
| Device Count | 5 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866035000343 [Primary] |
| GS1 | 10866035000340 [Unit of Use] |
| GS1 | 20866035000347 [Package] Package: [5 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-03 |
| Device Publish Date | 2019-05-24 |
| 00866035000305 - Shikani Speaking Valve | 2019-06-03 |
| 00866035000312 - Shikani Speaking Valve | 2019-06-03 |
| 00866035000343 - Shikani HME | 2019-06-03 |
| 00866035000343 - Shikani HME | 2019-06-03 |
| 00866035000350 - Shikani HME Oxygen Tube | 2019-06-03 |