FDA.reportPublic FDA data

Application set

Primary DI
05700693095219
Brand
Application set
Company
Radiometer Basel AG
Model
0607110
Catalog number
0607110
Device description
Application set
Published
2016-09-01
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
KLKMonitor, oxygen, cutaneous, for infant not under gas anesthesia
LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700693095219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700693095219057006930952195700693095219

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood gas monitor sensorA device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
481337657
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15700693095285Calibration Gas064021006402102016-09-01
05700693096216TOSCA-PC interface cable500010150001012016-09-01
05700693096223TOSCA-VueLink adapter cable500010050001002016-09-01
05700693096230TOSCA Open end interface cable 5V FS500011550001152016-09-01
05700693096247TOSCA Open end interface cable 1V FS500011650001162016-09-01
05700693096254TOSCA Open end nurse call cable500011750001172016-09-01
05700699031778TOSCA 500 Cable903-177903-1772016-09-01
05700699031785TOSCA 500 Cable903-178903-1782016-09-01
05700699031792TOSCA 500 Cable903-179903-1792016-09-01
05700699033413TCM4x Cable903-341903-3412016-09-01
05700699033420TOSCA 500 Cable903-342903-3422016-09-01
05700693095202Supplies for COMBI *M 82060520006052002016-09-01
05700693095233Adhesive rings060721006072102016-09-01
05700693095189COMBI *M sensor 82060500006050002016-09-01
05700693095226Application set Neonatal060712006071202016-09-01
05700693095240Adhesive rings060723006072302016-09-01
05700693095288Calibration Gas064021006402102016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSLKD2025-04-23
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSKLK2025-04-23
07640121880988103149 Calibration GasSenTec AGLKD2024-07-05
07640121880988103149 Calibration GasSenTec AGKLK2024-07-05
07640121880995103164 tCOM+SenTec AGLKD2024-07-05
07640121880995103164 tCOM+SenTec AGKLK2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGKLK2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGLKD2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGKLK2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGLKD2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGLKD2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGKLK2024-07-05
00899660002895Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.LKD2023-08-01
00899660002901Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.LKD2023-08-01
00899660002918Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.LKD2023-08-01
07640121881039Non-Adhesive WrapSenTec AGKLK2023-07-21
07640121881039Non-Adhesive WrapSenTec AGLKD2023-07-21
07640121880964Patient Application Kit for mature intact skinSenTec AGLKD2021-09-26
07640121880964Patient Application Kit for mature intact skinSenTec AGKLK2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGLKD2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGKLK2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGKLK2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGLKD2021-09-26
17640121880961Patient Application Kit for mature intact skinSenTec AGKLK2021-09-26
07640121880889SDM Water Protection CoverSenTec AGLKD2021-08-25
07640121880889SDM Water Protection CoverSenTec AGKLK2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGKLK2021-05-05
07640121880902Isolation Transformer 100-120VSenTec AGLKD2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGKLK2021-02-28
07640121880933Membrane Changer (single-use) / single unitSenTec AGLKD2021-02-28