| Primary Device ID | 05030267119981 |
| NIH Device Record Key | 3af72d44-b491-4ba3-8e3c-a6efeb38d011 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EasySpeak |
| Version Model Number | RM21351 |
| Company DUNS | 785952607 |
| Company Name | INTERSURGICAL INCORPORATED |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00619498213511 [Primary] |
| GS1 | 05030267119974 [Package] Contains: 00619498213511 Package: [20 Units] In Commercial Distribution |
| GS1 | 05030267119981 [Package] Contains: 00619498213511 Package: [80 Units] In Commercial Distribution |
| BYP | Mouthpiece, Breathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-09-24 |
| 05030267120000 | MOUTHPIECE, ANGLED, 22M |
| 05030267119813 | MOUTHPIECE, ANGLED, W/17CM TUBE 22F |
| 05030267119981 | 15M ANGLED NIV MOUTHPIECE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EASYSPEAK 87697528 5652795 Live/Registered |
King, Randall S. 2017-11-27 |
![]() EASYSPEAK 86010247 4795771 Live/Registered |
ResMed Limited 2013-07-15 |
![]() EASYSPEAK 78882493 3274905 Dead/Cancelled |
ResMed Limited 2006-05-12 |
![]() EASYSPEAK 75701657 2550484 Dead/Cancelled |
VoiceStream Wireless Corporation 1999-05-10 |
![]() EASYSPEAK 74019538 1641100 Dead/Cancelled |
Presbyterian Hospital of Dallas 1990-01-16 |