4PLY SURGICAL MASK

GUDID 08809783490532

UNICO GLOBAL INC

Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use Public face mask, single-use

• Primary Device ID: 08809783490532
• NIH Device Record Key: edaf8aaf-0725-460d-8c49-ef47b6ebb0cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4PLY SURGICAL MASK
• Version Model Number: FM-EU2002
• Company DUNS: 690513726
• Company Name: UNICO GLOBAL INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809783490532 [Unit of Use]
GS1	08809783490631 [Primary]

FDA Product Code

• QKR: Face Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency

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: 2022-03-28
• Device Publish Date: 2022-03-18

Devices Manufactured by UNICO GLOBAL INC

• 08809783490105 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490112 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490129 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490136 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490143 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490150 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490167 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28
• 08809783490174 - Unico Global Level 3 Surgical Gown (Film-Reinforced SMS): 2022-03-28