LoopView®

GUDID 16975339622142

LoopView®, Single-Use Digital Flexible Bronchoscope, B38-C

MacroLux Medical Technology Co., Ltd.

Flexible video bronchoscope, single-use

• Primary Device ID: 16975339622142
• NIH Device Record Key: 297d81e8-864c-4580-b1e1-e6ecdf1ade11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LoopView®
• Version Model Number: B38-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	06975339622145 [Primary]
GS1	16975339622142 [Package]; Contains: 06975339622145; Package: Box [5 Units]; In Commercial Distribution
GS1	26975339622149 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233779

FDA Product Code

• EOQ: Bronchoscope (Flexible Or 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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [LoopView®]

• 16975339622128: LoopView®, Single-Use Digital Flexible Bronchoscope, B38
• 16975339622234: LoopView®, Single-Use Digital Flexible Bronchoscope, B58-CG
• 16975339622227: LoopView®, Single-Use Digital Flexible Bronchoscope, B58-C
• 16975339622210: LoopView®, Single-Use Digital Flexible Bronchoscope, B58-G
• 16975339622203: LoopView®, Single-Use Digital Flexible Bronchoscope, B58
• 16975339622197: LoopView®, Single-Use Digital Flexible Bronchoscope, B50-CG
• 16975339622180: LoopView®, Single-Use Digital Flexible Bronchoscope, B50-C
• 16975339622173: LoopView®, Single-Use Digital Flexible Bronchoscope, B50-G
• 16975339622166: LoopView®, Single-Use Digital Flexible Bronchoscope, B50
• 16975339622159: LoopView®, Single-Use Digital Flexible Bronchoscope, B38-CG
• 16975339622142: LoopView®, Single-Use Digital Flexible Bronchoscope, B38-C
• 16975339622135: LoopView®, Single-Use Digital Flexible Bronchoscope, B38-G
• 16975339622265: LoopView®, Single-Use Digital Flexible Bronchoscope, B58-C, multi-language
• 16975339622258: LoopView®, Single-Use Digital Flexible Bronchoscope, B50-C, multi-language
• 16975339622241: LoopView®, Single-Use Digital Flexible Bronchoscope, B38-C, multi-language