Dr Trust

GUDID 00860002308203

NURECA, INC.

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: 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