FORA

GUDID 00816042014352

Disposable Surgical Face Mask (ASTM F2100 LEVEL3)

FORA CARE INC.

Surgical/medical face mask, single-use

• Primary Device ID: 00816042014352
• NIH Device Record Key: 4cba9c2c-d9a3-4286-a45b-56eaa2f9e0c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: ASTM-L3
• Company DUNS: 004340807
• Company Name: FORA CARE INC.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816042014352 [Primary]
GS1	80816042014358 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201549

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: 2021-11-22
• Device Publish Date: 2021-11-12

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