Disposable medical face masks

GUDID 16945060520215

The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.The non-sterile disposable medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile

Jiang Xi Sanxin Medtec Co., Ltd.

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

• Primary Device ID: 16945060520215
• NIH Device Record Key: 0fb82335-48c8-40a1-b495-87e7cf22b3bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable medical face masks
• Version Model Number: Type A (ear-loop type),size III,Sterile 9.5×15.5 L
• Company DUNS: 530079367
• Company Name: Jiang Xi Sanxin Medtec 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945060520218 [Primary]
GS1	16945060520215 [Package]; Contains: 06945060520218; Package: [50 Units]; In Commercial Distribution
GS1	26945060520212 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202719

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: 2025-03-27
• Device Publish Date: 2025-03-19

On-Brand Devices [Disposable medical face masks]

• 16945060520246: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520239: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520222: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520215: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520208: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520192: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520185: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520178: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520161: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520154: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520147: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520130: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520123: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520116: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520109: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520093: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520086: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520079: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520062: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520055: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520048: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520031: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520024: The sterile disposable medical face masks are intended for single use by operating room personne
• 16945060520017: The sterile disposable medical face masks are intended for single use by operating room personne