KIMBERLY-CLARK® Fluidshield* Fog-Free Surgical Mask

GUDID 00036000482478

Surgical Mask

KIMBERLY-CLARK GLOBAL SALES, LLC

Surgical/medical face mask, single-use

• Primary Device ID: 00036000482478
• NIH Device Record Key: 9508e006-61a3-4989-8b08-17535bf6c69b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIMBERLY-CLARK® Fluidshield* Fog-Free Surgical Mask
• Version Model Number: 48247
• Company DUNS: 830997032
• Company Name: KIMBERLY-CLARK GLOBAL SALES, LLC
• Device Count: 25
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)346-4652
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036000482478 [Primary]
GS1	10036000482475 [Package]; Package: Case [4 Units]; In Commercial Distribution
GS1	90036000482471 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823078

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-11-30

Devices Manufactured by KIMBERLY-CLARK GLOBAL SALES, LLC

• 10036000628705 - Kimtech Element Nitrile Exam Gloves (XS): 2021-07-22 Examination Gloves
• 10036000628712 - Kimtech Element Nitrile Exam Gloves (S): 2021-07-22 Examination Gloves
• 10036000628729 - Kimtech Element Nitrile Exam Gloves (M): 2021-07-22 Examination Gloves
• 10036000628736 - Kimtech Element Nitrile Exam Gloves (L): 2021-07-22 Examination Gloves
• 10036000628743 - Kimtech Element Nitrile Exam Gloves (XL): 2021-07-22 Examination Gloves
• 10036000628606 - Kimtech Opal Nitrile Exam Gloves (XS): 2021-05-18 Examination Gloves
• 10036000628613 - Kimtech Opal Nitrile Exam Gloves (S): 2021-05-18 Examination Gloves
• 10036000628620 - Kimtech Opal Nitrile Exam Gloves (M): 2021-05-18 Examination Gloves