BluSat

GUDID 10859998006337

Gentle Touch Neonatal Fabric Sensor

OSI OPTOELECTRONICS, INC.

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use

• Primary Device ID: 10859998006337
• NIH Device Record Key: 53c248e1-a9af-4c4f-892b-3a1c963450c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluSat
• Version Model Number: 4344
• 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	10859998006337 [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: 2021-02-10
• Device Publish Date: 2021-02-02

On-Brand Devices [BluSat]

• 00859998006361: Adult Finger Sensor
• 30859998006416: Adhesive Sensor Wrap, Universal
• 30859998006331: Gentle Touch Neonatal Fabric Sensor
• 30859998006324: Gentle Touch Infant Fabric Sensor
• 30859998006317: Gentle Touch Pediatric Fabric Sensor
• 30859998006300: Gentle Touch Adult Fabric Sensor
• 10859998006412: Adhesive Sensor Wrap, Universal
• 10859998006337: Gentle Touch Neonatal Fabric Sensor
• 10859998006320: Gentle Touch Infant Fabric Sensor
• 10859998006313: Gentle Touch Pediatric Fabric Sensor
• 10859998006306: Gentle Touch Adult Fabric Sensor
• 00859998006408: Patient Monitor Extension Cable
• 00859998006378: Adult Finger Sensor
• 00859998006354: Reusable Ear-Clip
• 00859998006347: Y-Sensor