| Primary Device ID | 10841470103122 | 
| NIH Device Record Key | c9fdc769-2bfe-41e0-b1a2-039d37d1ccb3 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pertrach | 
| Version Model Number | 301-D4551 | 
| Company DUNS | 154502934 | 
| Company Name | ENGINEERED MEDICAL SYSTEMS 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 | 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 | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 317-246-5500 | 
| info@engmedsys.com | 
| Lumen/Inner Diameter | 5.6 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00841470103125 [Primary] | 
| GS1 | 10841470103122 [Package] Contains: 00841470103125 Package: [5 Units] In Commercial Distribution | 
| BTO | Tube, Tracheostomy (W/Wo Connector) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-05-27 | 
| 10841470104396 | 301-D4550 | 
| 10841470104389 | 301-D4559 | 
| 10841470104372 | 301-D4558 | 
| 10841470104365 | 301-D4554 | 
| 10841470104358 | 301-D4552 | 
| 10841470104341 | 301-D4553 | 
| 10841470104334 | 301-D4556 | 
| 10841470104327 | 301-D4555 | 
| 10841470104310 | 301-D4557 | 
| 10841470103122 | 301-D4551 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PERTRACH  78269728  2865139 Live/Registered | Engineered Medical Systems, Inc. 2003-07-02 | 
|  PERTRACH  74162705  1694198 Dead/Cancelled | LUTHER MEDICAL PRODUCTS, INC. 1991-05-01 |