FDA.reportPublic FDA data

Ready Sensor™ GOLD Hct Sensor

Primary DI
00630414056296
Brand
Ready Sensor™ GOLD Hct Sensor
Company
Siemens Healthcare Diagnostics Inc.
Model
10309783
Catalog number
106042
Device description
Ready Sensor™ Hct Biosensor for in vitro use on the RapidLab® 348/348ex pH/Blood Gas 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
00630414056296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414056296006304140562966304140562960630414056296

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693930978ABL90 FLEXRadiometer Medical ApSJGS2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSJFP2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCHL2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCGZ2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJFP2026-07-09
05700699446572SP90Radiometer Medical ApSJFP2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09
05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSCGZ2026-07-09
05700699447579SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSJGS2026-07-09
05700699447579SP90Radiometer Medical ApSJFP2026-07-09
05700699447579SP90Radiometer Medical ApSCGZ2026-07-09
05700699447579SP90Radiometer Medical ApSCHL2026-07-09
05700699461056SC90Radiometer Medical ApSCGZ2026-07-09
05700699461056SC90Radiometer Medical ApSJGS2026-07-09
05700699461056SC90Radiometer Medical ApSJFP2026-07-09
05700699461056SC90Radiometer Medical ApSCEM2026-07-09
05700699461056SC90Radiometer Medical ApSCHL2026-07-09
05700699461087SC90Radiometer Medical ApSCHL2026-07-09
05700699461087SC90Radiometer Medical ApSJFP2026-07-09
05700699461087SC90Radiometer Medical ApSCEM2026-07-09
05700699461087SC90Radiometer Medical ApSJGS2026-07-09
05700699461087SC90Radiometer Medical ApSCGZ2026-07-09