Somanetics

GUDID 30817357022194

Cerebral/Somatic Oximetry Pediatric Sensor

HYGIA HEALTH SERVICES, INC.

Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 30817357022194
• NIH Device Record Key: c6a8d710-7d78-45d0-8d40-2da70aa75526
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Somanetics
• Version Model Number: SPFB-USA
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	10817357022190 [Primary]
GS1	30817357022194 [Package]; Contains: 10817357022190; Package: Box [20 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100523

FDA Product Code

• NMD: Oximeter, Tissue Saturation, Reprocessed

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: 2021-03-19
• Device Publish Date: 2017-02-04

On-Brand Devices [Somanetics]

• 30817357022194: Cerebral/Somatic Oximetry Pediatric Sensor
• 30817357020541: Cerebral/Somatic Oximetry Adult Sensor