Surgi-Plus 68-8518-B

GUDID 84895237109112

The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. the mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile, meet ASTM F2100 LEVEL 3. The Surgical Mask is single use, three-layer, flat –folded masks with ties and nose wire. This Mask is manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mask close to the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in green and Blue. The surgical mask is sold non-sterile and are intended to be single use, disposable device.

KENPAX INTERNATIONAL LIMITED

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• Primary Device ID: 84895237109112
• NIH Device Record Key: 265cb741-b879-461a-ae80-5c75120d540a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgi-Plus
• Version Model Number: 1
• Catalog Number: 68-8518-B
• Company DUNS: 686206765
• Company Name: KENPAX INTERNATIONAL LIMITED
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	74895237109115 [Primary]
GS1	84895237109112 [Package]; Contains: 74895237109115; Package: Case [20 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: 2020-07-10
• Device Publish Date: 2020-07-02

On-Brand Devices [Surgi-Plus]

• 04895237100137: Procedure Mask
• 74895237109122: Surgical Mask
• 04895237102124: PE Film Gown
• 84895237109112: The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel fr
• 84895237106036: PE Film Gown
• 74895237106015: PE Film Gown