MediBio TD-8255 Fingertip Pulse Oximeter

GUDID 00850014981020

MEDIBIO USA LLC

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: 00850014981020
• NIH Device Record Key: 8dcf0aa0-43f1-4084-b59f-1f83792cf802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediBio TD-8255 Fingertip Pulse Oximeter
• Version Model Number: TD-8255
• Company DUNS: 012481654
• Company Name: MEDIBIO USA LLC
• 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: false
• 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	00850014981020 [Primary]

FDA Product Code

• DQA: Oximeter

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: 2020-01-31
• Device Publish Date: 2020-01-23

Devices Manufactured by MEDIBIO USA LLC

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• 00850014981006 - MediBio TD-3140 Blood Pressure Monitor: 2020-01-31
• 00850014981013 - Medibio TD-4277 Blood Glucose Monitoring System: 2020-01-31
• 00850014981020 - MediBio TD-8255 Fingertip Pulse Oximeter: 2020-01-31
• 00850014981020 - MediBio TD-8255 Fingertip Pulse Oximeter: 2020-01-31
• 00850014981037 - MediBio TD-2555 Weight Scale: 2020-01-31