Solaris

GUDID 56900234150115

Philips Compatible Adult SpO2 Soft-Finger Sensor (1.6m cable)

Solaris Medical Technology, Inc.

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 56900234150115
• NIH Device Record Key: 5ac36c16-dfa0-4422-bbc0-6a0f90b6bbb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solaris
• Version Model Number: T100A-160087
• Company DUNS: 527945351
• Company Name: Solaris Medical Technology, 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: 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	06900234100115 [Primary]
GS1	16900234110111 [Package]; Contains: 06900234100115; Package: box [20 Units]; In Commercial Distribution
GS1	26900234120117 [Package]; Contains: 06900234100115; Package: box [32 Units]; In Commercial Distribution
GS1	36900234130113 [Package]; Contains: 06900234100115; Package: box [40 Units]; In Commercial Distribution
GS1	46900234140119 [Package]; Contains: 06900234100115; Package: box [60 Units]; In Commercial Distribution
GS1	56900234150115 [Package]; Contains: 06900234100115; Package: box [80 Units]; In Commercial Distribution
GS1	66900234160111 [Package]; Contains: 06900234100115; Package: box [100 Units]; In Commercial Distribution
GS1	66900234160227 [Package]; Contains: 06900234100115; Package: box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100077

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: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-23

On-Brand Devices [Solaris]

• 56900234150221: Philips Compatible Adult SpO2 Soft-Finger Sensor (3.0m cable)
• 56900234150115: Philips Compatible Adult SpO2 Soft-Finger Sensor (1.6m cable)
• 56900234100097: Nonin Compatible Adult SpO2 Finger Sensor (0.9m Cable)
• 56900234100080: BCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)
• 06900234100207: Philips Compatible Pediatric SpO2 Soft-Finger Sensor (0.9m cable)
• 06900234100191: Philips Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)