MEDICOM SAFEMASK PREMIER 204215

GUDID 00686864057000

SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP BLEU L3

AMD Medicom Inc

Surgical/medical face mask, single-use

• Primary Device ID: 00686864057000
• NIH Device Record Key: ca172b6e-9771-49ea-881d-40b4fba3edf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICOM SAFEMASK PREMIER
• Version Model Number: 204215
• Catalog Number: 204215
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 25
• 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: 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
• 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
• 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
• 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
• 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	00686864057000 [Unit of Use]
GS1	10686864057007 [Primary]
GS1	20686864057004 [Package]; Contains: 10686864057007; Package: OUTER CASE [4 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-31
• Device Publish Date: 2020-08-21

On-Brand Devices [MEDICOM SAFEMASK PREMIER]

• 20686864109086: SAFEMASK PREMIER ELITE EARLOOP PINK
• 20686864045155: SAFEMASK PREMIER EARLOOP WHITE
• 10686864040764: MEDICOM SAFEMASK PREMIER SAMPLE PACK
• 20686864027113: SAFEMASK PREMIER PLUS EARLOOP BLUE
• 20686864027052: SAFEMASK PREMIER ELITE EARLOOP BLUE
• 20686864027045: SAFEMASK PREMIER EARLOOP TEAL
• 20686864024518: SAFEMASK PREMIER EARLOOP PINK
• 20686864023399: SAFEMASK PREMIER EARLOOP LAVENDER
• 20686864011020: SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP TEAL
• 20686864008365: SAFEMASK PREMIER EARLOOP YELLOW
• 20686864002950: SAFEMASK PREMIER EARLOOP BLUE
• 00686864057000: SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP BLEU L3
• 00686864056737: SAFEMASK PREMIER Pediatric Procedure Masks Earloop L1/Recommended age: 4 -12
• 00686864057017: SAFEMASK PREMIER ELITE PROSHIELD VISOR EARLOOP PINK L3