Leadtek

GUDID 00190263830121

LEADTEK RESEARCH, INC.

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• 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