FDA.reportPublic FDA data

TCM 4 series ETX base unit

Primary DI
05700693918808
Brand
TCM 4 series ETX base unit
Company
Radiometer Medical ApS
Model
391-880
Catalog number
391-880
Device description
TCM 4 series ETX base unit
Published
2025-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPZOximeter, ear
DQAOximeter
KLKMonitor, oxygen, cutaneous, for infant not under gas anesthesia
LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS
LPPMonitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700693918808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700693918808057006939188085700693918808

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood gas monitoring systemAn assembly of mains electricity (AC-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 and connecting cables may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+459999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
1
Serial number
true

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05700699566140safePICO70956-614956-6142016-09-01
05700699566157safePICO70956-615956-6152016-09-01
05700699566164safePICO70956-616956-6162016-09-01
05700699566232safePICO956-623956-6232016-09-01
05700699566249safePICO70956-624956-6242016-09-01
05700699056894TC contact liquid905-689905-6892016-09-01
05700693930978ABL90 FLEX393-097393-0972026-07-09
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05700699446572SP90944-657944-6572026-07-09
05700699447579SP90944-757944-7572026-07-09
05700699461056SC90946-105946-1052026-07-09
05700699461087SC90946-108946-1082026-07-09

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