Solairs

GUDID 06900234100108

Nonin Compatible Adult SpO2 Soft-Finger Sensor (3.0m cable)

Solaris Medical Technology, Inc.

Pulse oximeter probe, reusable

• Primary Device ID: 06900234100108
• NIH Device Record Key: dae5cafb-14b5-4ac0-9fdc-3e12f9f92546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solairs
• Version Model Number: T100A-300110
• 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	06900234100108 [Primary]
GS1	16900234100105 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	26900234100102 [Package]; Package: Box [32 Units]; In Commercial Distribution
GS1	36900234100109 [Package]; Package: Box [40 Units]; In Commercial Distribution
GS1	46900234100106 [Package]; Package: Box [60 Units]; In Commercial Distribution
GS1	56900234100103 [Package]; Package: Box [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: 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)