Contact Gel 2ml

GUDID 07640121880858

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 Sensor is to be att

SenTec AG

Pulse Co-oximeter probe, reusable

• Primary Device ID: 07640121880858
• NIH Device Record Key: e1bd03c4-1db1-4406-855d-fdd294217648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contact Gel 2ml
• 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: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041548

FDA Product Code

• LPP: Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

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: 2019-03-18
• Device Publish Date: 2019-03-08

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• EIT11ST2721000 - 1ST272-100 LuMon™ Belt Size 19: 2025-09-16
• EIT11ST2731000 - 1ST273-100 LuMon™ Belt Size 22: 2025-09-16
• EIT11ST2741000 - 1ST274-100 LuMon™ Belt Size 26: 2025-09-16
• EIT11ST2751000 - 1ST275-100 LuMon™ Belt Size 30: 2025-09-16
• EIT11ST2761000 - 1ST276-100 LuMon™ Belt Size 35: 2025-09-16
• EIT11ST2771000 - 1ST277-100 LuMon™ Belt Size 40: 2025-09-16