Pocket Monitor

GUDID 06971176280159

This device is intended to be used for processing the image signal received from Pusen single use laryngoscope and display the image.

Zhuhai Pusen Medical Technology Co, Ltd

Endoscopic video image processing unit

• Primary Device ID: 06971176280159
• NIH Device Record Key: f1a8b5f7-fff0-415b-b463-a5517ed96fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pocket Monitor
• Version Model Number: VL100
• Company DUNS: 544427443
• Company Name: Zhuhai Pusen Medical Technology Co, Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06971176280159 [Primary]

FDA Product Code

• FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-29
• Device Publish Date: 2022-03-21

Devices Manufactured by Zhuhai Pusen Medical Technology Co, Ltd

• 16971176281528 - Single use biopsy forceps PGB: 2025-02-19 The single use biopsy forceps is intended to be used through working channel of endoscope to remove tissue samples.
• 16971176281542 - Single use grasping forceps PGA: 2025-02-19 The single use grasping forceps is intended to be used through working channel of endoscope to remove foreign bodies.
• 16971176281405 - Uscope: 2024-11-08 This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipmen
• 16971176281412 - Uscope: 2024-11-08 This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipmen
• 16971176281429 - Uscope: 2024-11-08 This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipmen
• 16971176281436 - Uscope: 2024-11-08 This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipmen
• 16971176281443 - Uscope: 2024-11-08 This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipmen
• 16971176281450 - Uscope: 2024-11-08 This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipmen