| 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 |