Dolphin

GUDID 00859998006293

Neonatal / Adult Disposable Oximetry 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

• Primary Device ID: 00859998006293
• NIH Device Record Key: 000a2cb6-57c1-4bcc-b789-773bf4af3532
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dolphin
• Version Model Number: 2314
• 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	00859998006293 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-11

On-Brand Devices [Dolphin]

• 00859998006293: Neonatal / Adult Disposable Oximetry Sensor
• 00859998006286: Infant Disposable Oximetry Sensor
• 00859998006279: Pediatric Disposable Oximetry Sensor
• 00859998006262: Adult Disposable Oximetry Sensor
• 00859998006255: Adult Disposable Oximetry Sensor
• 00859998006248: Adult Disposable Oximetry Sensor
• 00859998006231: Pediatric Disposable Probe
• 00859998006224: Pediatric Disposable Probe
• 00859998006217: Infant Disposable Probe
• 00859998006200: Neonatal / Adult Disposable Oximetry Sensor
• 00859998006156: Y Multi-Site Resuable Oximery Sensor
• 00859998006071: Adult Resuable Oximetry Sensor