| Primary Device ID | 05030267163571 |
| NIH Device Record Key | 57c69452-ac33-4612-9770-86bca62382ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATION OXYGEN MASK AND TUBE, 2.1M |
| Version Model Number | 1181017 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 05030267157891 [Primary] |
| GS1 | 05030267163571 [Package] Contains: 05030267157891 Package: [24 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-17 |
| Device Publish Date | 2024-10-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INTERSURGICAL ECOLITE 86274433 4687510 Live/Registered |
Intersurgical Limited 2014-05-07 |