Solaris

GUDID 56900234100080

BCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)

Solaris Medical Technology, Inc.

Pulse oximeter probe, reusable

• Primary Device ID: 56900234100080
• NIH Device Record Key: 644f68d8-4232-4acf-8dcb-eb84c5a4fd29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solaris
• Version Model Number: T200A-090101
• 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	06900234100085 [Primary]
GS1	16900234100082 [Package]; Contains: 06900234100085; Package: [20 Units]; In Commercial Distribution
GS1	26900234100089 [Package]; Contains: 06900234100085; Package: [32 Units]; In Commercial Distribution
GS1	36900234100086 [Package]; Contains: 06900234100085; Package: [40 Units]; In Commercial Distribution
GS1	46900234100083 [Package]; Contains: 06900234100085; Package: [60 Units]; In Commercial Distribution
GS1	56900234100080 [Package]; Contains: 06900234100085; Package: [80 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: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-11-24

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)