MEDICOM SAFEMASK SOFSKIN 2089

GUDID 20686864056274

SAFEMASK SOFSKIN EARLOOP LAVANDER LEVEL 3

AMD Medicom Inc

Surgical/medical face mask, single-use
Primary Device ID20686864056274
NIH Device Record Key6d85a58d-ea9f-455e-9936-254b37c5bd3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDICOM SAFEMASK SOFSKIN
Version Model Number2089
Catalog Number2089
Company DUNS256880576
Company NameAMD Medicom Inc
Device Count50
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca
Phone+1(514)636-6262
Emailmdasilva@medicom.ca

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100686864056270 [Unit of Use]
GS110686864056277 [Primary]
GS120686864056274 [Package]
Contains: 10686864056277
Package: OUTER CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [MEDICOM SAFEMASK SOFSKIN]

20686864037280SAFEMASK SOFSKIN EARLOOP LAVENDER
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20686864037242SAFEMASK SOFSKIN EARLOOP BLUE
20686864037228SAFEMASK SOFSKIN EARLOOP WHITE
20686864056274SAFEMASK SOFSKIN EARLOOP LAVANDER LEVEL 3
20686864056267SAFEMASK SOFSKIN EARLOOP PINK LEVEL 3
20686864056250SAFEMASK SOFSKIN EARLOOP BLUE LEVEL 3
20686864056243SAFEMASK SOFSKIN EARLOOP WHITE LEVEL 3
20686864060721SafeMask SofSkin ClearFit, Procedure Earloop Face Masks with Fog Free Strip and Chin Fit, Level
20686864060714SafeMask SofSkin Fit, Procedure Earloop Face Masks with Chin Fit, Level 3, White

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