Pulse Oximeter

GUDID 06938368113022

General Meditech. Inc.

Pulse oximeter

• Primary Device ID: 06938368113022
• NIH Device Record Key: a273f1ac-9bc3-4642-b422-21ee55bb53cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Oximeter
• Version Model Number: G1B Plus
• Company DUNS: 545261786
• Company Name: General Meditech. Inc.
• 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	06938368113022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082789

FDA Product Code

• DQA: Oximeter

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: 2024-09-11
• Device Publish Date: 2024-09-03

On-Brand Devices [Pulse Oximeter]

• 06938368100411: G1B
• 06938368113022: G1B Plus