SpiroLink

GUDID 06970397220012

This device is intended to monitor a patient’s Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.

Guangzhou Red Elephant Medical Technology Co.,Ltd

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• Primary Device ID: 06970397220012
• NIH Device Record Key: b311b0fe-f6ba-46db-a7ab-ba15420ab78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroLink
• Version Model Number: B1
• Company DUNS: 544581675
• Company Name: Guangzhou Red Elephant 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn
• Phone: +860208095414
• Email: service@huxijia.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970397220012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191239

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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: 2021-03-19
• Device Publish Date: 2019-12-19