MEDICOM SAFEMASK PREMIER SMPREMIER US-SP

GUDID 10686864040764

MEDICOM SAFEMASK PREMIER SAMPLE PACK

AMD Medicom Inc

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 10686864040764
• NIH Device Record Key: a604efd0-76d7-413b-9c65-8584162b136c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICOM SAFEMASK PREMIER
• Version Model Number: SMPREMIER US-SP
• Catalog Number: SMPREMIER US-SP
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 3
• 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: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: amdudi@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca
• Phone: 1514-636-6262
• Email: mkansou@medicom.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864040767 [Unit of Use]
GS1	10686864040764 [Primary]

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: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-02-28

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