Solairs

GUDID 06900234100054

BCI Compatible Adult SpO2 Finger Sensor (3.0m 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: 06900234100054
• NIH Device Record Key: a573baac-85c3-43ed-9e28-54b9de4f8f6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solairs
• Version Model Number: S200A-300101
• 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	06900234100054 [Primary]
GS1	16900234100051 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	26900234100058 [Package]; Package: Box [32 Units]; In Commercial Distribution
GS1	36900234100055 [Package]; Package: Box [40 Units]; In Commercial Distribution
GS1	46900234100052 [Package]; Package: Box [60 Units]; In Commercial Distribution
GS1	56900234100059 [Package]; Package: Box [80 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061931

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: 2017-06-16

On-Brand Devices [Solairs]

• 06900234100108: Nonin Compatible Adult SpO2 Soft-Finger Sensor (3.0m cable)
• 06900234100054: BCI Compatible Adult SpO2 Finger Sensor (3.0m cable)
• 06900234100047: BCI Compatible Adult SpO2 Finger Sensor (0.9m cable)
• 06900234100177: Nonin Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)