Oximeter

GUDID 06938368100015

General Meditech. Inc.

Pulse oximeter, battery-powered

• Primary Device ID: 06938368100015
• NIH Device Record Key: eee91da1-e693-4c9a-b4ef-461fd5a12bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oximeter
• Version Model Number: G1B
• 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	06938368100008 [Primary]
GS1	06938368100015 [Package]; Contains: 06938368100008; Package: [1 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-19

On-Brand Devices [Oximeter]

• 06938368100039: G1B Plus
• 06938368100015: G1B