Membrane Changer Inserts

GUDID 07640121880506

The Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTec TC Sensors. Prior reuse, the Membrane Changer (MC-R) must be reloade

SenTec AG

Transcutaneous blood gas monitoring system

• Primary Device ID: 07640121880506
• NIH Device Record Key: 924a54fb-43ba-44e8-b928-ff4f707c26d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Membrane Changer Inserts
• Version Model Number: MC-I
• 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

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *during transport: 0-50 °C

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640121880506 [Primary]
GS1	17640121880503 [Package]; Package: Box [5 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

• 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