Nfuze

GUDID 06972620115683

BQ PLUS MEDICAL CO., LTD.

Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set Electronic gravity infusion controller administration set

• Primary Device ID: 06972620115683
• NIH Device Record Key: ad678393-1784-4cb4-80e7-6ba740b22fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nfuze
• Version Model Number: CSN002
• 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	06972620115683 [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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Nfuze]

• 26972620118879: PFS103
• 26972620118862: MKN000
• 26972620118855: MJN002
• 26972620118848: EJN004
• 26972620118831: EJN002
• 26972620115762: SS300
• 26972620115731: MSN002
• 26972620115700: CSN002
• 26972620115670: MLN002
• 26972620115649: ELN002
• 16972620118872: PFS103
• 16972620118865: MKN000
• 16972620118858: MJN002
• 16972620118841: EJN004
• 16972620118834: EJN002
• 16972620115758: SS300
• 16972620115727: MSN002
• 16972620115697: CSN002
• 16972620115666: MLN002
• 16972620115635: ELN002
• 06972620118875: PFS103
• 06972620118868: MKN000
• 06972620118851: MJN002
• 06972620118844: EJN004
• 06972620118837: EJN002
• 06972620115744: SS300
• 06972620115713: MSN002
• 06972620115683: CSN002
• 06972620115652: MLN002
• 06972620115621: ELN002