TCM 4 series ETX base unit 391-880

GUDID 05700693918808

TCM 4 series ETX base unit

Radiometer Medical ApS

Transcutaneous blood gas monitoring system

• Primary Device ID: 05700693918808
• NIH Device Record Key: 114ffe0b-ba29-4f6e-bf67-df909bd567de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCM 4 series ETX base unit
• Version Model Number: 391-880
• Catalog Number: 391-880
• Company DUNS: 308667539
• Company Name: Radiometer Medical ApS
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700693918808 [Primary]

FDA Product Code

• DPZ: Oximeter, ear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-01
• Device Publish Date: 2025-04-23

Devices Manufactured by Radiometer Medical ApS

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• 05700693918808 - TCM 4 series ETX base unit: 2025-05-01 TCM 4 series ETX base unit
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• 05700699460509 - SC90 50 BG, LYT, MET, OXI + QC: 2024-07-09 SC90 50 BG, LYT, MET, OXI + QC
• 55700699428764 - CLINITUBES D941G-NA-240-85X10: 2023-04-20 D941G-NA-240-85x10 CLINITUBES 10 vials of 75 units, Multipack
• 55700699044391 - CAPILLARY CAPS, RED 160pcs.: 2022-12-13 Capillary Caps, Red bag of 160 units
• 55700699044537 - CAPILLARY CAPS, green 110pcs.: 2022-12-13 Capillary Caps, Green bag of 110 units
• 55700699056615 - CLINITUBES D956G-70-35*1: 2022-12-13 D956G-70-35x1 CLINITUBES 1 vial of 75 units. 35 µL. Multipack w. accessories
• 55700699060223 - ABL77 CAPILLARY ADAPTERS: 2022-12-13 Capillary adaptor vented, 100 pcs. for ABL77