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

• 07640121881053 - 103583 LuMon™ Contact Gel Kit: 2025-09-16
• EIT11ST1201000 - 1ST120-100 LuMon™ Connector 2.0: 2025-09-16 The LuMon Connector 2.0 is a reusable adapter intended to link a LuMon™ Belt to the LuMon™ Monitor.
• 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