MCG Diagnostics

GUDID 00810016251620

PREVENT II FILTER-OVAL-WHITE

MEDICAL GRAPHICS CORPORATION

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 00810016251620
• NIH Device Record Key: a74028e6-52fb-4abc-af4f-98f9eec127e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCG Diagnostics
• Version Model Number: 536757-EW
• Company DUNS: 094045622
• Company Name: MEDICAL GRAPHICS 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810016251620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042758

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2019-06-10
• Device Publish Date: 2019-06-01

On-Brand Devices [MCG Diagnostics]

• B3687000239060: Express Series CCM
• 00810016251620: PREVENT II FILTER-OVAL-WHITE
• 00810016250289: FILTER KIT 2