FDA.reportPublic FDA data

TOSCA Open end interface cable 1V FS

Primary DI
05700693096247
Brand
TOSCA Open end interface cable 1V FS
Company
Radiometer Basel AG
Model
5000116
Catalog number
5000116
Device description
TOSCA Open end interface cable 1V FS
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
DPZOximeter, ear
DQAOximeter
LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700693096247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700693096247057006930962475700693096247

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.

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

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
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
05700693095219Application set060711006071102016-09-01
05700693095226Application set Neonatal060712006071202016-09-01
05700693095240Adhesive rings060723006072302016-09-01
05700693095288Calibration Gas064021006402102016-09-01

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