Jointown 2082

GUDID 00850017230026

Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.

U.S. HEALTH EXPRESS CORP.

Surgical/medical face mask, single-use

• Primary Device ID: 00850017230026
• NIH Device Record Key: 9350696b-5d89-4ea9-8ff8-d1144d15ae4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jointown
• Version Model Number: 2082Blue
• Catalog Number: 2082
• Company DUNS: 081037169
• Company Name: U.S. HEALTH EXPRESS CORP.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 16268102005
• Email: yaomin@ehaoyao.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017230002 [Primary]
GS1	00850017230026 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182514

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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-03-18