Criterion 5703277

GUDID 30304040168968

Ultrasoft Sensitive Earloop Mask L3 Pink, 50 Box, 40 Boxes/Case

HENRY SCHEIN, INC.

Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 30304040168968
• NIH Device Record Key: 63940f4f-64cd-4dff-ac57-cf3850ef70d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Criterion
• Version Model Number: 5703277
• Catalog Number: 5703277
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• 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: false
• 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	00304040168967 [Primary]
GS1	30304040168968 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103303

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: 3
• Public Version Date: 2023-12-05
• Device Publish Date: 2023-06-26

On-Brand Devices [Criterion]

• 00304040168981: MaxiGard SFT Earloop Mask L3, Pink, 50/Box
• 00304040168974: MaxiGard SFT Earloop Mask L3, Blue, 50/Box
• 00304040168967: Ultrasoft Sensitive Earloop Mask L3 Pink, 50 Box, 40 Boxes/Case
• 00304040168950: Ultrasoft Earloop Mask L3, Blue
• 00304040168943: Earloop Mask Anti-Fog ASTM Level 1 Pink
• 00304040168936: Earloop Mask Anti-Fog ASTM Level 1 White
• 00304040168929: Earloop Mask Anti-Fog ASTM Level 1 Lavender
• 00304040168653: Earloop Mask Anti-Fog ASTM Level 3 Pink
• 00304040168646: Earloop Mask Anti-Fog ASTM Level 3 White
• 00304040168622: Earloop Masks Anti-Fog ASTM Level 3 Blue
• 00304040168615: Earloop Mask ASTM Level 3 Teal
• 00304040168585: Earloop Mask Omega Pleat ASTM Level 3 Blue
• 00304040168493: Earloop mask level 3 black
• 00304040168486: Earloop mask level l black
• 00304040165263: Earloop Mask with EyeShield L3
• 00304040165256: Tie on Surgical Mask Level 1, Blue
• 00304040169049: Tie On Surgical Mask L3 Blue
• 30304040168982: MaxiGard SFT Earloop Mask L3, Pink, 50/Box
• 30304040168975: MaxiGard SFT Earloop Mask L3, Blue, 50/Box
• 30304040168968: Ultrasoft Sensitive Earloop Mask L3 Pink, 50 Box, 40 Boxes/Case
• 30304040168951: Ultrasoft Earloop Mask L3, Blue
• 00304040177976: Maxi-Gard Dual Fabric Cover Gown, Blue
• 00304040177969: Polycoated Apron, White
• 00304040177952: Cover Gown, Pink, Fluid Resistant
• 00304040172100: Cover Gown, Blue, Fluid Resistant
• 00304040172094: Cover Gown, Pink, Fluid Resistant
• 00304040172087: Disposable Fluid Resistant Cover Gown, Blue, XL