ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask

GUDID 04710415360045

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The face masks are single use, disposable device, provided non-sterile.

MEDTECS (TAIWAN) CORP.

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

• Primary Device ID: 04710415360045
• NIH Device Record Key: 81c522f1-2b22-4b24-9bc7-c355b7859097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask
• Version Model Number: FM-140G
• Company DUNS: 658023890
• Company Name: MEDTECS (TAIWAN) CORP.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710415360045 [Primary]
GS1	04710415369819 [Unit of Use]
GS1	14710415360042 [Package]; Package: Case [40 Units]; In Commercial Distribution

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: 2022-03-31
• Device Publish Date: 2022-03-23

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