TruLink 21-00812

GUDID 00859998006484

SpO2 Vinyl Sensor Single-patient Use - Pediatric

OSI OPTOELECTRONICS, INC.

Pulse oximeter probe, single-use

• Primary Device ID: 00859998006484
• NIH Device Record Key: 69f3053e-52d5-4215-8c90-7b6d36cb4273
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruLink
• Version Model Number: 015-0665-00
• Catalog Number: 21-00812
• Company DUNS: 612770974
• Company Name: OSI OPTOELECTRONICS, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859998006484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030952

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: 2021-03-04
• Device Publish Date: 2021-02-24

On-Brand Devices [TruLink]

• 00859998006507: SpO2 Vinyl Sensor Single-Patient Use - Adult
• 00859998006491: SpO2 Foam Sensor Single-patient Use Adult
• 00859998006484: SpO2 Vinyl Sensor Single-patient Use - Pediatric
• 00859998006477: SpO2 Foam Sensor Single-Patient Use - Pediatric
• 00859998006460: SpO2 Cloth Sensor Single-Patient Use - Infant
• 00859998006453: SpO2 Cloth Sensor Single-patient Use - Neonate
• 00859998006446: SpO2 Y Multi-Site Sensor Reusable -Universal
• 00859998006439: SpO2 Finger Sensor Reusable - Adult