TruZone®

GUDID 00604351965010

MONAGHAN MEDICAL CORPORATION

Peak flow meter, manual

• Primary Device ID: 00604351965010
• NIH Device Record Key: 807748ba-a2ac-4353-a876-b68895e65228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruZone®
• Version Model Number: Peak Flow Meter, Single
• Company DUNS: 056332380
• Company Name: MONAGHAN MEDICAL CORPORATION
• Device Count: 1
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 518-561-7330
• Email: customerservice@monaghanmed.com
• Phone: 518-561-7330
• Email: customerservice@monaghanmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00604351965010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031514

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [TruZone®]

• 50604351965107: Peak Flow Meter, cs/10
• 00604351965010: Peak Flow Meter, Single