| Primary Device ID | 10850108006889 |
| NIH Device Record Key | d0774f4f-9c47-4684-86ef-380fc0b37813 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trach O-Life |
| Version Model Number | RTG-04016 |
| Catalog Number | RTG-04016 |
| Company DUNS | 080216804 |
| Company Name | CUTTING EDGE HC BRANDS LLC |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 9999999999 |
| info@rtghealth.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850108006882 [Primary] |
| GS1 | 10850108006889 [Package] Contains: 00850108006882 Package: Carton [50 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-11 |
| Device Publish Date | 2019-02-25 |
| 10850108006896 | Pediatric Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask |
| 10850108006889 | Adult Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask is |