Contact Gel

GUDID 07640121880070

The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be at

SenTec AG

Transcutaneous blood gas monitoring system

• Primary Device ID: 07640121880070
• NIH Device Record Key: e5a98c9b-b8b8-420c-bee8-c0d69c895e28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contact Gel
• Version Model Number: GEL-04
• Company DUNS: 480797856
• Company Name: SenTec AG
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041548

FDA Product Code

• DPZ: Oximeter, Ear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Contact Gel]

• 07640121880070: The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTe
• 17640121880862: The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec