Ear Clip

GUDID 07640121880049

The Ear Clip is required to attach SenTec TC Sensors to the patient’s earlobe. Suitable for patients with earlobes of sufficient size and mature, inta

SenTec AG

Transcutaneous blood gas monitoring system

• Primary Device ID: 07640121880049
• NIH Device Record Key: 248ef429-a348-4daf-88b8-6855a8ffae1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ear Clip
• Version Model Number: EC-MI
• Company DUNS: 480797856
• Company Name: SenTec AG
• Device Count: 1
• DM Exempt: true
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50°C
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880049 [Primary]
GS1	17640121880046 [Package]; Package: Box [24 Units]; In Commercial Distribution

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

Devices Manufactured by SenTec AG

• 07640121880988 - 103149 Calibration Gas: 2024-07-15 The Calibration Gas serves as calibration gas for the Sentec transcutaneous sensors that monitor tcPCO2 and/or tcPO2 (V-Sign™
• 07640121880995 - 103164 tCOM+: 2024-07-15 The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patien
• 07640121881008 - 103420 Sensor Adapter Cable (Regular): 2024-07-15 The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCO
• 07640121881015 - 103421 Sensor Adapter Cable (Long): 2024-07-15 The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCO
• 07640121881022 - 103422 Sensor Adapter Cable (Extra Long): 2024-07-15 The Sensor Adapter Cable is required to connect digital Sentec sensors (V-Sign™ Sensor 2, OxiVenT™ Sensor) to the Sentec tCO
• 17640121881036 - Non-Adhesive Wrap: 2023-07-31 Sentec’s Non-Adhesive Wrap is intended to be wrapped around the thigh of neonatal patients with very sensitive/fragile skin fo
• 07640121880957 - Patient Application Kit with Ear Clip for mature/intact skin: 2021-10-04 A combination of single-use products intended to attach the Sentec sensors to the earlobe of the patient, recommended for patien
• 17640121880961 - Patient Application Kit for mature intact skin: 2021-10-04 A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for ad