MEDICOM SAFEMASK SOFSKIN 2080

GUDID 20686864037228

SAFEMASK SOFSKIN EARLOOP WHITE

AMD Medicom Inc

Surgical/medical face mask, single-use

• Primary Device ID: 20686864037228
• NIH Device Record Key: d7f9c079-25d9-411f-b51f-151922be9565
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICOM SAFEMASK SOFSKIN
• Version Model Number: 2080
• Catalog Number: 2080
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 50
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: amdudi@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864037224 [Unit of Use]
GS1	10686864037221 [Primary]
GS1	20686864037228 [Package]; Contains: 10686864037221; Package: OUTER CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-15

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