Dr Trust

GUDID 00860002308203

NURECA, INC.

Pulse oximeter, battery-powered

• Primary Device ID: 00860002308203
• NIH Device Record Key: dc3b716d-85cc-4ff5-8ce2-c88b39692ded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr Trust
• Version Model Number: A310
• Company DUNS: 081092844
• Company Name: NURECA, 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002308203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153021

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: 2
• Public Version Date: 2019-10-22
• Device Publish Date: 2019-08-09

On-Brand Devices [Dr Trust]

• 00860002308203: A310
• 08906101765676: BP116A
• 00860002308234: A310
• 08906101765546: DMT-437