FDA.reportPublic FDA data

O2 module for the TCM4XX Series

Primary DI
05700699025647
Brand
O2 module for the TCM4XX Series
Company
Radiometer Medical ApS
Model
902-564
Catalog number
902-564
Device description
O2 module for the TCM4XX Series
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPPMonitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001866000TCM400Radiometer Medical A/S2000-12-07LPP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699025647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699025647057006990256475700699025647

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 Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 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
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700693930978ABL90 FLEX393-097393-0972026-07-09
05700693930985ABL90 FLEX PLUS393-098393-0982026-07-09
05700699446572SP90944-657944-6572026-07-09
05700699447579SP90944-757944-7572026-07-09
05700699461056SC90946-105946-1052026-07-09
05700699461087SC90946-108946-1082026-07-09
05700699461094SC90946-109946-1092026-07-09
05700699461100SC90946-110946-1102026-07-09
05700699461131SC90946-113946-1132026-07-09
05700699461605SC90946-160946-1602026-07-09
05700699428929SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05
05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
05700699428981SAFE CLINITUBES D957P-70-70X1942-898942-8982024-07-01
05700699429698safeClinitubes D957P-70-45942-969942-9692022-12-05
05700699440174QUALICHECK 5+, LEVEL 1944-017944-0172022-12-05
05700699440198QUALICHECK 5+, LEVEL 3944-019944-0192022-12-05
05700699440822AUTOCHECK 3+, LEVEL 1, S7335944-082944-0822022-12-05
05700699440839AUTOCHECK 3+, LEVEL 2, S7345944-083944-0832022-12-05
05700699440846AUTOCHECK 3+, LEVEL 3, S7355944-084944-0842022-12-05
05700699440853AUTOCHECK 3+, LEVEL 4, S7365944-085944-0852022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSLPP2025-04-23
07640121880988103149 Calibration GasSenTec AGLPP2024-07-05
07640121880995103164 tCOM+SenTec AGLPP2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGLPP2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGLPP2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGLPP2024-07-05
07640121881039Non-Adhesive WrapSenTec AGLPP2023-07-21
07332834000790PF 6840-1 TC Remote Panel 1 ChannelPerimed ABLPP2023-02-01
07332834000806PF 6840-2 TC Remote Panel 2 ChannelsPerimed ABLPP2023-02-01
07332834000820PF 6840-4 TC Remote Panel 4 ChannelsPerimed ABLPP2023-02-01
07640121880964Patient Application Kit for mature intact skinSenTec AGLPP2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGLPP2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGLPP2021-09-26
07640121880889SDM Water Protection CoverSenTec AGLPP2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGLPP2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGLPP2021-02-28
07640121880810Ear Clip easySenTec AGLPP2020-03-31
17640121880817Ear Clip easySenTec AGLPP2020-03-31
07640121880858Contact Gel 2mlSenTec AGLPP2019-03-08
17640121880862Contact GelSenTec AGLPP2019-03-05
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinSenTec AGLPP2019-01-29
07640121880797Multi-Site Attachment Ring for mature/intact skinSenTec AGLPP2019-01-29
17640121880800Multi-Site Attachment Ring for fragile/sensitive sSenTec AGLPP2019-01-29
07640121880315PSG-XSenTec AGLPP2018-11-12
07640121880612PSG Cable ASenTec AGLPP2018-11-12
07640121880629PSG Cable BSenTec AGLPP2018-11-12
07640121880636PSG Cable CSenTec AGLPP2018-11-12
07640121880643PSG Cable DSenTec AGLPP2018-11-12
07640121880650PSG Cable ESenTec AGLPP2018-11-12
07640121880667PSG Cable FSenTec AGLPP2018-11-12