TCM 4 series ETX base unit

Basic Information

• Brand Name: TCM 4 series ETX base unit
• Primary DI: 05700693918808
• Version / Model: 391-880
• Catalog Number: 391-880
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-23
• Public Version: 4
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: 114ffe0b-ba29-4f6e-bf67-df909bd567de
• Distribution End Date: 2025-10-29

Device Description

TCM 4 series ETX base unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPZ	Oximeter, ear	Cardiovascular	870.2710	2
DQA	Oximeter	Cardiovascular	870.2700	2
KLK	Monitor, oxygen, cutaneous, for infant not under gas anesthesia	Anesthesiology	868.2500	2
LPP	Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia	Anesthesiology	868.2500	2
LKD	MONITOR, CARBON-DIOXIDE, CUTANEOUS	Anesthesiology	868.2480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46934	Transcutaneous blood gas monitoring system	An assembly of electrically-powered devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives, connecting cables, and coupling/contact gel may be supplied as part of the system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700693918808	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity