| Primary Device ID | 00381342000768 |
| NIH Device Record Key | 668bcefd-b96d-4c19-b7e7-c1ee628844c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Health Supply US Level 2 Gown |
| Version Model Number | HSUS-L2-EC-S |
| Catalog Number | HSUS-L2-EC-S |
| Company DUNS | 117465816 |
| Company Name | Health Supply US, LLC |
| Device Count | 10 |
| 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 | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381342000591 [Primary] |
| GS1 | 00381342000768 [Unit of Use] |
| GS1 | 00381342000775 [Package] Contains: 00381342000591 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 10381342000772 [Package] Contains: 00381342000775 Package: Pallet [12 Units] In Commercial Distribution |
| OEA | Non-Surgical Gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-26 |
| Device Publish Date | 2024-06-18 |
| 00381342000768 | Pack of 10 L2 SMS non-sterile Isolation Gowns |
| 00381342000799 | Pack of 10 Level 2 non-sterile isolation gown |
| 00381342000829 | Pack of 10 Level 2 SMS non-sterile isolation gowns |
| 00381342000744 | Pack of 10 Level 2 non-sterile, single-use, isolation gowns - gowns are not sold individually |
| 00381342000751 | Package of 10 single-use, non-sterile L2 SMS isolation gowns - gowns are not sold individually. |