Handheld Pulse Monitor

GUDID 06932562310058

The monitor is indicated for spot checking of functional arterial SpO2(BLT-SpO2), and pulse rate of patient.

Guangdong Biolight Meditech Co., Ltd.

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 06932562310058
• NIH Device Record Key: 6d85a21b-2d55-446b-8dc4-12f792d8ab17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handheld Pulse Monitor
• Version Model Number: M800
• Company DUNS: 530120146
• Company Name: Guangdong Biolight Meditech 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06932562310058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101694

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by Guangdong Biolight Meditech Co., Ltd.

• 06932562310355 - Fingertip Pluse Oximeter: 2024-04-08
• 06932562310362 - handheld monitor: 2024-04-08
• 06932562310317 - Fingertip Pulse Oximeter: 2021-11-10
• 06932562310324 - Fingertip Pulse Oximeter: 2021-11-10
• 06932562310348 - Fingertip Pulse Oximeter: 2021-07-06
• 06932562310331 - patient monitor: 2020-08-18
• 06932562310300 - Vital Signs Monitor: 2020-02-06
• 06932562310089 - Patient Monitor: 2020-02-06 The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological paramet