Disposable Pressure Manometer 566

GUDID 50851232007757

The disposable pressure manometer provides visual indication of airway pressure.

D R BURTON HEALTHCARE, LLC

Airway pressure monitor, non-powered

• Primary Device ID: 50851232007757
• NIH Device Record Key: 9997e7cc-d542-4005-a6c9-e1748e5a982e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Pressure Manometer
• Version Model Number: 1
• Catalog Number: 566
• Company DUNS: 080384219
• Company Name: D R BURTON HEALTHCARE, LLC
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 2522287038
• Email: inquiries@drburtonhpi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851232007759 [Primary]
GS1	50851232007757 [Package]; Contains: 10851232007759; Package: CASE [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192000

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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: 2020-03-09
• Device Publish Date: 2020-02-28

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