FDA.reportPublic FDA data

Calibration Gas

Primary DI
15700693095285
Brand
Calibration Gas
Company
Radiometer Basel AG
Model
0640210
Catalog number
0640210
Device description
CAL gas 6 cyl.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700693095288PackageGS16In Commercial Distribution
15700693095285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700693095288057006930952885700693095288
1570069309528515700693095285

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 Temperature4 Degrees Celsius30 Degrees Celsius

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

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Primary DI, Brand, Company table
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