FACE MASKS

GUDID 08056646503216

3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - YELLOW

OMNIA SRL

Surgical/medical face mask, single-use

• Primary Device ID: 08056646503216
• NIH Device Record Key: 52acd50d-f487-4ec4-ac82-2ffcc5786359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FACE MASKS
• Version Model Number: 30.M1304.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• 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: 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: false

Customer Support Contacts

• Phone: +390524527453
• Email: info@omniaspa.eu

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT AND KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646503209 [Unit of Use]
GS1	08056646503216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911334

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-03-06

On-Brand Devices [FACE MASKS]

• 08056646503216: 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - YELLOW
• 08056646501441: 3-LAYER FACE MASK WITH SPLASHGUARD VISOR AND ELASTIC BANDS - LIGHT BLUE
• 08056646501427: 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - PURPLE
• 08056646501403: 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - ORANGE
• 08056646501380: 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - WITH PRINTING
• 08056646501366: 3-LAYER FACE MASK WITH STRINGS - LIGHT GREEN
• 08056646501342: 3-LAYER FACE MASK WITH STRINGS - LIGHT BLUE
• 08056646501328: 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - BLUE
• 08056646501298: 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - GREEN