Nfuze

GUDID 16972620115635

BQ PLUS MEDICAL CO., LTD.

Electronic gravity infusion controller administration set

• Primary Device ID: 16972620115635
• NIH Device Record Key: ca2417ae-e066-4002-8d8e-90f36a4a72e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nfuze
• Version Model Number: ELN002
• 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	16972620115635 [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