FDA.reportPublic FDA data

TOSCA 500 Cable

Primary DI
05700699031785
Brand
TOSCA 500 Cable
Company
Radiometer Basel AG
Model
903-178
Catalog number
903-178
Device description
TOSCA 500 Embla interface cable
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
05700699031785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699031785057006990317855700699031785

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
05700693096247TOSCA Open end interface cable 1V FS500011650001162016-09-01
05700693096254TOSCA Open end nurse call cable500011750001172016-09-01
05700699031778TOSCA 500 Cable903-177903-1772016-09-01
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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10884521855403NellcorCovidien LPDQA2026-05-29
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