Medical Graphics

GUDID 00810016250555

SW Ascent 2.0

MEDICAL GRAPHICS CORPORATION

Pulmonary function analysis system, adult

• Primary Device ID: 00810016250555
• NIH Device Record Key: f801b55e-efe0-4e1d-aa22-74160e691a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical Graphics
• Version Model Number: 147999-004
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810016250555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181912

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2023-07-26
• Device Publish Date: 2023-07-18

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