Breathe-EZ

GUDID 00850025860048

Breathe-EZ Bite Bloc Adult 60Fr Elastic

Micro-tech Usa

Endoscopic bite block, basic, single-use

• Primary Device ID: 00850025860048
• NIH Device Record Key: d614fcc7-9e1e-4260-bb73-8f6f273a3662
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breathe-EZ
• Version Model Number: MDBB1AY003A
• Company DUNS: 079873914
• Company Name: Micro-tech Usa
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025860031 [Primary]
GS1	00850025860048 [Package]; Contains: 00850025860031; Package: Box [50 Units]; In Commercial Distribution
GS1	00850025860055 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• MNK: Endoscopic Bite Block

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: 2025-03-11
• Device Publish Date: 2025-03-03

On-Brand Devices [Breathe-EZ]

• 00858276007755: Breathe-EZ
• 00850025860048: Breathe-EZ Bite Bloc Adult 60Fr Elastic