| Primary Device ID | 05030267088850 |
| NIH Device Record Key | c775fd45-b6a8-428a-b539-a8e6f114531e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HARNESS SMALL FOR CPAP FACE MASK |
| Version Model Number | 2223000 |
| 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 | 05030267063956 [Primary] |
| GS1 | 05030267088850 [Package] Contains: 05030267063956 Package: [12 Units] In Commercial Distribution |
| GS1 | 05030267088867 [Package] Contains: 05030267063956 Package: [48 Units] In Commercial Distribution |
| BTK | Strap, Head, Gas Mask |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |