Zhou Medical N95 Respirator Mask Z120101

GUDID B820Z1201010

Zhou Medical N95 NIOSH Respirator Mask

ZHOU MEDICAL SOLUTIONS LLC

Surgical/medical respirator, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use
Primary Device IDB820Z1201010
NIH Device Record Key08b2d310-c0e9-4cf6-b128-33525cf5e2de
Commercial Distribution StatusIn Commercial Distribution
Brand NameZhou Medical N95 Respirator Mask
Version Model Number1
Catalog NumberZ120101
Company DUNS081373840
Company NameZHOU MEDICAL SOLUTIONS LLC
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com
Phone713-389-5544
Emailinfo@zhoumedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB820Z1201010 [Primary]
HIBCCB820Z1201011 [Unit of Use]

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-06
Device Publish Date2019-12-11

Devices Manufactured by ZHOU MEDICAL SOLUTIONS LLC

B820Z1201010 - Zhou Medical N95 Respirator Mask2020-05-06Zhou Medical N95 NIOSH Respirator Mask
B820Z1201010 - Zhou Medical N95 Respirator Mask2020-05-06 Zhou Medical N95 NIOSH Respirator Mask
B820Z1201020 - Zhou Medical N95 Respirator Mask - S2020-05-06 Zhou Medical N95 NIOSH Respirator Mask - Small
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