Breathing Filter

GUDID 16959180703878

VR Medical Technology Co., Ltd.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 16959180703878
• NIH Device Record Key: 019b42f2-2b96-406f-bf7a-703787ef56fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breathing Filter
• Version Model Number: VR010
• 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	16959180703878 [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: 2016-09-02

Devices Manufactured by VR Medical Technology Co., Ltd.

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• 16959180703731 - Closed Suction System: 2020-05-14
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• 16959180704318 - Closed Suction System: 2020-05-14
• 16959180704332 - Closed Suction System: 2020-05-14