SafeSecure

GUDID 06973563061815

Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd

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

• Primary Device ID: 06973563061815
• NIH Device Record Key: deff7e9c-2d7d-4aa1-af50-efbad757f2fa
• Commercial Distribution Discontinuation: 2033-01-16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSecure
• Version Model Number: EH-1
• Company DUNS: 527295522
• Company Name: Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd
• Device Count: 20
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com
• Phone: +8675527040468
• Email: tse@anbaopack.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973563061815 [Unit of Use]
GS1	16973563061812 [Primary]
GS1	26973563061819 [Package]; Contains: 16973563061812; Package: carton [45 Units]; Discontinued: 2033-01-16; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213358

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-28
• Device Publish Date: 2022-07-20