TUTEM 6055-14 FUTURE DESIGN

GUDID 10817583020489

EARLOOP, TUTEM- FUTURE DESIGN

ALPHA PRO TECH INC

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood Surgical hood

• Primary Device ID: 10817583020489
• NIH Device Record Key: 5c9234e0-7678-4a13-8757-a8dc75f108e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUTEM
• Version Model Number: 6055-14 FUTURE DESIGN
• Catalog Number: 6055-14 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	00817583020482 [Primary]
GS1	10817583020489 [Package]; Contains: 00817583020482; 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