| 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  |