Avante/Pacific

GUDID 06900234100245

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

Solaris Medical Technology, Inc.

Pulse oximeter probe, reusable

• Primary Device ID: 06900234100245
• NIH Device Record Key: 54b6106d-2b14-4db8-a2dd-0c9826463040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avante/Pacific
• Version Model Number: NSPH3020
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06900234100245 [Primary]
GS1	16900234100242 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	26900234100249 [Package]; Package: Box [32 Units]; In Commercial Distribution
GS1	36900234100246 [Package]; Package: Box [40 Units]; In Commercial Distribution
GS1	46900234100243 [Package]; Package: Box [60 Units]; In Commercial Distribution
GS1	56900234100240 [Package]; Package: Box [80 Units]; In Commercial Distribution
GS1	66900234100247 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-28
• Device Publish Date: 2020-01-20

Devices Manufactured by Solaris Medical Technology, Inc.

• 06900234100245 - Avante/Pacific: 2020-01-28Philips Compatible Reusable SpO2 Adult Soft-Finger Sensor (3.0m cable)
• 06900234100245 - Avante/Pacific: 2020-01-28 Philips Compatible Reusable SpO2 Adult Soft-Finger Sensor (3.0m cable)
• 06900234100177 - Solairs: 2020-01-20 Nonin Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)
• 06900234100191 - Solaris: 2020-01-20 Philips Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)
• 06900234100207 - Solaris: 2020-01-17 Philips Compatible Pediatric SpO2 Soft-Finger Sensor (0.9m cable)
• 66900234100025 - None: 2020-01-16 Reusable Adult SpO2 Sensor for Use with Commander III device.
• 06900234100047 - Solairs: 2020-01-09 BCI Compatible Adult SpO2 Finger Sensor (0.9m cable)
• 06900234100054 - Solairs: 2020-01-09 BCI Compatible Adult SpO2 Finger Sensor (3.0m cable)
• 56900234100080 - Solaris: 2020-01-09 BCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)