Cool Breathe

GUDID D8063145BL0

Cool Breathe ear loop mask with middle bar

MAYTEX CORPORATION

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

• Primary Device ID: D8063145BL0
• NIH Device Record Key: f3ad0a11-5df0-4bf3-9c5c-f3b9f5b6d317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cool Breathe
• Version Model Number: 3145BL
• 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: false
• 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	D8063145BL0 [Unit of Use]
HIBCC	D8063145BL1 [Primary]

FDA Product Code

• FXX: Mask, Surgical

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: 2024-06-19
• Device Publish Date: 2024-06-11

Devices Manufactured by MAYTEX CORPORATION

• D8063145BL0 - Cool Breathe: 2024-06-19Cool Breathe ear loop mask with middle bar
• D8063145BL0 - Cool Breathe: 2024-06-19 Cool Breathe ear loop mask with middle bar
• D8066050B0 - Maytex: 2024-06-19 Barrier Gown Blue
• D8066050BXL0 - Maytex: 2024-06-18 Barrier gown blue XL
• D8066250TL0 - Maytex: 2024-06-18 Lab coat teal medium
• D8066250TM0 - Maytex: 2024-06-18 Lab coat teal medium
• D8066250TS0 - Maytex: 2024-06-18 Lab coat teal small
• D8066250TXL0 - Maytex: 2024-06-18 Lab coat teal XL
• D8065875VBL0 - Maytex: 2022-10-21 SensiTouch nitrile exam glove Large blue