BubbleView®

GUDID 16975339621176

BubbleView®, Single-Use Digital Flexible Cystoscope, C50-C

MacroLux Medical Technology Co., Ltd.

Flexible video cystoscope, single-use

• Primary Device ID: 16975339621176
• NIH Device Record Key: 47fb2c82-f5c3-49e7-801a-c7b1a019a7c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BubbleView®
• Version Model Number: C50-C
• Company DUNS: 723490133
• Company Name: MacroLux Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975339621179 [Primary]
GS1	16975339621176 [Package]; Contains: 06975339621179; Package: box [5 Units]; In Commercial Distribution
GS1	26975339621173 [Package]; Package: carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240283

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

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: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [BubbleView®]

• 16975339621206: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CBR
• 16975339621190: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CB
• 16975339621183: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CR
• 16975339621176: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-C