BQ+

GUDID 06972620111197

BQ PLUS MEDICAL CO., LTD.

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• Primary Device ID: 06972620111197
• NIH Device Record Key: 682f7c8a-07ca-4ac8-8eb8-62e533d4adcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BQ+
• Version Model Number: BW/IVF-3041230
• Company DUNS: 544463583
• Company Name: BQ PLUS MEDICAL 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	06972620111197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210381

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-04
• Device Publish Date: 2022-06-25

On-Brand Devices [BQ+]

• 16972620111200: BW/IVF-3041230
• 16972620111187: BW/IV-3041185
• 06972620111197: BW/IVF-3041230
• 06972620111173: BW/IV-3041185