HEPA Breathing Filter

GUDID 16959180703885

VR Medical Technology Co., Ltd.

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• Primary Device ID: 16959180703885
• NIH Device Record Key: 77b6ed9a-3a4e-454a-8277-1965ead395a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEPA Breathing Filter
• Version Model Number: VR012
• Company DUNS: 420798349
• Company Name: VR Medical Technology Co., Ltd.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16959180703885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132709

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2019-11-27
• Device Publish Date: 2016-09-20

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