MEDICOM SAFEMASK MASTER SERIES 2057

GUDID 10686864047664

SAFEMASK MASTER SERIES EARLOOP OCEAN SURF L3

AMD Medicom Inc

Surgical/medical face mask, single-use

• Primary Device ID: 10686864047664
• NIH Device Record Key: 7127d1e6-afdf-49a2-83ac-373ed99587d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICOM SAFEMASK MASTER SERIES
• Version Model Number: 2057
• Catalog Number: 2057
• 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: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca

Operating and Storage Conditions

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864047667 [Unit of Use]
GS1	10686864047664 [Primary]
GS1	20686864047661 [Package]; 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: 2017-04-06

On-Brand Devices [MEDICOM SAFEMASK MASTER SERIES]

• 10686864047688: SAFEMASK MASTER EARLOOP SOUTHERN BELL FLOWER L3
• 10686864047671: SAFEMASK MASTER EARLOOP AZALEA FESTIVAL L3
• 10686864047664: SAFEMASK MASTER SERIES EARLOOP OCEAN SURF L3
• 20686864047654: SAFEMASK MASTER EARLOOP OCEAN SURF L2
• 20686864046268: SAFEMASK MASTER SERIES EARLOOP SOUTHERN BELLFLOWER L1
• 10686864040757: MEDICOM SAFEMASK MASTER SERIES SAMPLE PACK
• 20686864040297: SAFEMASK MASTER SERIES EARLOOP LUSH LAWN L1
• 20686864040273: SAFEMASK MASTER SERIES EARLOOP AZALEA FESTIVAL L1
• 20686864040259: SAFEMASK MASTER SERIES EARLOOP AUGUSTA SKY L1