Standard Procedure Mask

GUDID 16971705242709

Mask color: White

JiangSu MedPlus Non-Woven Manufacturer Co., Ltd

Surgical/medical face mask, single-use

• Primary Device ID: 16971705242709
• NIH Device Record Key: 8c06ec60-184f-4112-9978-ff72f9fffcd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Procedure Mask
• Version Model Number: Elastic ear-loop
• Company DUNS: 543264338
• Company Name: JiangSu MedPlus Non-Woven Manufacturer 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: false
• 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	06971705242702 [Primary]
GS1	16971705242709 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202605

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: 2021-04-15
• Device Publish Date: 2021-04-07

On-Brand Devices [Standard Procedure Mask]

• 16971705242709: Mask color: White
• 16971705240712: Mask color: Blue