Leadtek

GUDID 00190263830121

LEADTEK RESEARCH, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00190263830121
• NIH Device Record Key: fe279152-870e-4eae-9643-2cc6c4cf6f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leadtek
• Version Model Number: AU2C
• Company DUNS: 656171121
• Company Name: LEADTEK RESEARCH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190263830121 [Primary]

FDA Product Code

• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [Leadtek]

• 00190263830121: AU2C
• 00190263830114: AU2B