FDA.reportPublic FDA data

RAPIDLab® 348/348EX HCT Slope

Primary DI
00630414055930
Brand
RAPIDLab® 348/348EX HCT Slope
Company
Siemens Healthcare Diagnostics Inc.
Model
10309776
Catalog number
105670
Device description
RAPIDLab® 348/348EX HCT Slope for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962021000CIBA CORNING 348 SYSTEMCiba Corning Diagnostics Corp.1996-06-24CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414055930PrimaryGS10
00630414010045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414055930006304140559306304140559300630414055930
00630414010045006304140100456304140100450630414010045

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
10
Lot or batch
true
Expiration date on label
true

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