Strive®

GUDID 00604351966109

MONAGHAN MEDICAL CORPORATION

Peak flow meter, manual

• Primary Device ID: 00604351966109
• NIH Device Record Key: bd14cbd3-ffb8-4ae1-80da-2219b3505e49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strive®
• Version Model Number: Peak Flow Meter, cs/10
• 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	00604351966109 [Primary]
GS1	50604351966104 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123945

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: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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