| Primary Device ID | B820Z1201020 | 
| NIH Device Record Key | 6ce8a1f1-47e2-4a06-bc89-15a5ff3ab767 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Zhou Medical N95 Respirator Mask - S | 
| Version Model Number | 1 | 
| Catalog Number | Z120102 | 
| Company DUNS | 081373840 | 
| Company Name | ZHOU MEDICAL SOLUTIONS LLC | 
| Device Count | 6 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| 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 | 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 | false | 
| OTC Over-The-Counter | false | 
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | |
| Phone | 713-389-5544 | 
| info@zhoumedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B820Z1201020 [Primary] | 
| HIBCC | B820Z1201021 [Unit of Use] | 
| FXX | Mask, Surgical | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2020-05-06 | 
| Device Publish Date | 2019-12-11 | 
| B820Z1201010 - Zhou Medical N95 Respirator Mask | 2020-05-06 Zhou Medical N95 NIOSH Respirator Mask | 
| B820Z1201020 - Zhou Medical N95 Respirator Mask - S | 2020-05-06Zhou Medical N95 NIOSH Respirator Mask - Small | 
| B820Z1201020 - Zhou Medical N95 Respirator Mask - S | 2020-05-06 Zhou Medical N95 NIOSH Respirator Mask - Small |