WYZ Face Mask

GUDID 00860004437871

ASTM LEVEL 1 FACE MASK BLUE

Wyz Medical Supplies LLC

Surgical/medical face mask, single-use
Primary Device ID00860004437871
NIH Device Record Keye0e6be19-3e72-403c-97d4-eb18c0aa809e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWYZ Face Mask
Version Model Number2111
Company DUNS117528113
Company NameWyz Medical Supplies LLC
Device Count50
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004437864 [Primary]
GS100860004437871 [Package]
Contains: 00860004437864
Package: Outer Case [40 Units]
In Commercial Distribution
GS100860004437888 [Unit of Use]

FDA Product Code

LYUAccessory, Surgical Apparel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

On-Brand Devices [WYZ Face Mask]

00860004437833ASTM LEVEL 2 FACE MASK BLUE
00860004437871ASTM LEVEL 1 FACE MASK BLUE

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