Heat Moisture Exchanger and Filter

GUDID 16959180705513

VR Medical Technology Co., Ltd.

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• Primary Device ID: 16959180705513
• NIH Device Record Key: 8ac2105d-8c3b-4f76-9cc0-0df03b6bcbf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heat Moisture Exchanger and Filter
• Version Model Number: VR023
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16959180705513 [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: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-08-20

Devices Manufactured by VR Medical Technology Co., Ltd.

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• 16959180704417 - Closed Suction System: 2020-05-14
• 16959180704431 - Closed Suction System: 2020-05-14
• 16959180704448 - Closed Suction System: 2020-05-14
• 16959180705513 - Heat Moisture Exchanger and Filter: 2019-11-27
• 16959180705513 - Heat Moisture Exchanger and Filter: 2019-11-27