Maytex Ultra Safety

GUDID D8063135B1

Level 3 ear loop mask

MAYTEX CORPORATION

Surgical/medical respirator, single-use

• Primary Device ID: D8063135B1
• NIH Device Record Key: 171c4821-70a6-42cd-91ab-f8a384e36c0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maytex Ultra Safety
• Version Model Number: 3135B
• Company DUNS: 196642151
• Company Name: MAYTEX CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8063135B0 [Unit of Use]
HIBCC	D8063135B1 [Primary]

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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-07-04

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• D8066250TS0 - Maytex: 2024-06-18 Lab coat teal small
• D8066250TXL0 - Maytex: 2024-06-18 Lab coat teal XL
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