Neonatal Starter Set

GUDID 07640121880438

Neonatal Starter Set contains: Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR

SenTec AG

Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system Transcutaneous blood gas monitoring system

• Primary Device ID: 07640121880438
• NIH Device Record Key: 6d59538c-954b-453c-a3c1-3cb4a54fc101
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Starter Set
• Version Model Number: SSET-N
• 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: true
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880438 [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

Devices Manufactured by SenTec AG

• 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
• 17640121880978 - Patient Application Kit for sensitive/fragile skin: 2021-10-04 A combination of single-use products intended to attach the Sentec Sensors to conventional measurement sites, recommended for ad
• 07640121880889 - SDM Water Protection Cover: 2021-09-02 This cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2).
• 07640121880902 - Isolation Transformer 100-120V: 2021-05-13 Isolates the SDM from mains for use in home use environments.
• 07640121880933 - Membrane Changer (single-use) / single unit: 2021-03-08 The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane mus
• 17640121880817 - Ear Clip easy: 2020-04-08 Single patient use sensor application ear clip, recommended for adult, pediatric and neonatal patients with mature/intact skin