Surgical Face Mask

GUDID 16973062321585

Foshan Nanhai Plus Medical Co., Ltd

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

• Primary Device ID: 16973062321585
• NIH Device Record Key: 3b888de3-7a58-4c21-941e-15822021376f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Face Mask
• Version Model Number: 533-005
• Company DUNS: 529796225
• Company Name: Foshan Nanhai Plus Medical Co., Ltd
• Device Count: 1
• 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	06973062321588 [Primary]
GS1	16973062321585 [Package]; Contains: 06973062321588; Package: [4 Units]; In Commercial Distribution
GS1	26973062321582 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212610

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: 2022-03-01
• Device Publish Date: 2022-02-21

On-Brand Devices [Surgical Face Mask]

• 16973062321592: 533-006
• 16973062321585: 533-005
• 16973062321578: 533-004
• 16973062321561: 533-003
• 16973062321554: 533-002
• 16973062321547: 533-001
• 16973062321530: 522-006
• 16973062321523: 522-005
• 16973062321516: 522-004
• 16973062321509: 522-003
• 16973062321493: 522-002
• 16973062321486: 522-001