FDA.reportPublic FDA data

Synchron

Primary DI
15099590233518
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
472515
Catalog number
472515
Device description
SYNCHRON Systems CO2 Alkaline Buffer
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JFLPh Rate Measurement, Carbon-Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042291000UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc.2004-11-12CEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590233518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023351815099590233518

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide electrodeAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403015955Flush SolutionDiamond Diagnostics Inc.JFL2023-06-05
00817302024012CAROLINA LIQUID CHEMISTRIES CORP.® FAST DETERGENT 2 ACID WASHING SOLUTION 100262CAROLINA LIQUID CHEMISTRIES CORPORATIONJFL2022-07-06
00630414606460epoc Host2Epocal IncJFL2020-07-15
00630414606095epoc NXS HostEpocal IncJFL2020-06-18
10054749005519i-STATABBOTT POINT OF CARE INC.JFL2020-05-01
04050659367975mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368057mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368217mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368293mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368828mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371248mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371682mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371743mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371750mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659372214mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659372276mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373631mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373655mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373693mahe medical GmbHmahe medical gmbhJFL2019-11-05
EMAH3601319SL0HF-roller ball resectoscopy electrode, roller diam.3.0mm,24Chmahe medical gmbhJFL2018-12-10
EMAH3500915QL0Lithotripsy Telescope bridge w.7Ch. working channelmahe medical gmbhJFL2018-02-05
00630414596518Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-Siemens Healthcare Diagnostics Inc.JFL2017-12-22
00385480183420NOVANOVA BIOMEDICAL CORPORATIONJFL2017-04-24
EMAH36014240Roller barrel resectoscopy electrode, 24Ch.,roller diam.3.0mmmahe medical gmbhJFL2017-02-09
00842768014017Dimension® QuikLYTE® Integrated Multisensor Sample DiluentSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014024Dimension® QuikLYTE® Integrated Multisensor Diluent CheckSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014291Dimension® QuikLYTE® Multisensor Na+/K+/Cl-Siemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014307Dimension® QuikLYTE® Multisensor Flush SolutionSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00385480001250NOVANOVA BIOMEDICAL CORPORATIONJFL2016-09-20
00385480215886NOVANOVA BIOMEDICAL CORPORATIONJFL2016-09-20