Face Mask earloop

GUDID 16973479070021

SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO.,LTD.

Surgical/medical face mask, single-use

• Primary Device ID: 16973479070021
• NIH Device Record Key: b751a047-f536-47ff-9903-3c9aa54edc2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Face Mask earloop
• Version Model Number: NM-MA-010
• Company DUNS: 421090090
• Company Name: SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO.,LTD.
• Device Count: 50
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973479070024 [Primary]
GS1	16973479070021 [Unit of Use]

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-02
• Device Publish Date: 2020-06-24

Devices Manufactured by SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO.,LTD.

• 16973479070014 - Face Mask with shield tie on: 2020-07-02
• 16973479070021 - Face Mask earloop: 2020-07-02
• 16973479070021 - Face Mask earloop: 2020-07-02
• 16973479070038 - Face Mask tie on: 2020-07-02
• 16973479070045 - Face Mask with shield earloop: 2020-07-02