Fingertip Pluse Oximter

GUDID 06932562310003

Guangdong Biolight Meditech Co., Ltd.

Pulse oximeter, battery-powered

• Primary Device ID: 06932562310003
• NIH Device Record Key: aa8e41bd-0db0-4ef1-a531-39965f1d03dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fingertip Pluse Oximter
• Version Model Number: M70
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932562310003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151287

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: 2016-09-07

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