Zhou Medical N95 Respirator Mask Z120101

GUDID B820Z1201010

Surgical/medical respirator, single-use

Primary Device ID	B820Z1201010
NIH Device Record Key	08b2d310-c0e9-4cf6-b128-33525cf5e2de
Commercial Distribution Status	In Commercial Distribution
Brand Name	Zhou Medical N95 Respirator Mask
Version Model Number	1
Catalog Number	Z120101
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

Device Issuing Agency	Device ID
HIBCC	B820Z1201010 [Primary]
HIBCC	B820Z1201011 [Unit of Use]

FXX	Mask, Surgical

Steralize Prior To Use	false
Device Is Sterile	true

B820Z1201010 - Zhou Medical N95 Respirator Mask	2020-05-06Zhou Medical N95 NIOSH Respirator Mask
B820Z1201010 - Zhou Medical N95 Respirator Mask	2020-05-06 Zhou Medical N95 NIOSH Respirator Mask
B820Z1201020 - Zhou Medical N95 Respirator Mask - S	2020-05-06 Zhou Medical N95 NIOSH Respirator Mask - Small