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 |