TUTEM 6055-12 FUTURE DESIGN

GUDID 10817583020465

EARLOOP, TUTEM- FUTURE DESIGN

ALPHA PRO TECH INC

Surgical/medical face mask, single-use

• Primary Device ID: 10817583020465
• NIH Device Record Key: 997e696a-9f9b-4d8b-a816-8c856d6da6f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUTEM
• Version Model Number: 6055-12 FUTURE DESIGN
• Catalog Number: 6055-12 FUTURE DESIGN
• Company DUNS: 003687733
• Company Name: ALPHA PRO TECH INC
• Device Count: 1
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817583020468 [Primary]
GS1	10817583020465 [Package]; Contains: 00817583020468; Package: CASE [3000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875172

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: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-11-03

On-Brand Devices [TUTEM]

• 10817583020496: EARLOOP, TUTEM- FUTURE DESIGN
• 10817583020489: EARLOOP, TUTEM- FUTURE DESIGN
• 10817583020472: EARLOOP, TUTEM- FUTURE DESIGN
• 10817583020465: EARLOOP, TUTEM- FUTURE DESIGN
• 10817583020458: EARLOOP, TUTEM- OH BABY
• 10817583020441: EARLOOP, TUTEM-BABY GIRL.
• 10817583020434: EARLOOP, TUTEM-BABY BOY
• 10817583020427: EARLOOP, TUTEM-MASK TRANSIT
• 10817583020410: EARLOOP, TUTEM-GENTLE MANNERS
• 10817583020403: EARLOOP, TUTEM- KEEP IT TO YOURSELF.
• 10817583020397: EARLOOP, TUTEM-COLD COUTURE.
• 10817583020380: EARLOOP, TUTEM-MICROBE MANAGER
• 10817583020373: EARLOOP, TUTEM-DON'T GO VIRAL
• 10817583020366: EARLOOP, TUTEM-BUSINESS CLASS
• 10817583020359: EARLOOP, TUTEM -SOCIAL BUTTERFLY