Fingertip Pluse Oximeter

GUDID 06932562310010

Guangdong Biolight Meditech Co., Ltd.

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• Primary Device ID: 06932562310010
• NIH Device Record Key: c3ad6adf-7f01-40e5-a89e-14c027ac7d6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fingertip Pluse Oximeter
• Version Model Number: M70A
• 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	06932562310010 [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: 2016-09-20

On-Brand Devices [Fingertip Pluse Oximeter]

• 06932562310256: M70B
• 06932562310027: M70C
• 06932562310010: M70A
• 06932562310355: M70D