Somanetics

GUDID 30817357020541

Cerebral/Somatic Oximetry Adult Sensor 

HYGIA HEALTH SERVICES, INC.

Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed Tissue saturation oximeter sensor, reprocessed

• Primary Device ID: 30817357020541
• NIH Device Record Key: c525463c-13dc-4727-ab38-5e0c8c4e5298
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Somanetics
• Version Model Number: SAFB-SM
• 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	10817357020547 [Primary]
GS1	30817357020541 [Package]; Contains: 10817357020547; 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: 2016-09-22

On-Brand Devices [Somanetics]

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