FDA.reportPublic FDA data

Add Pack Hemo Control DM

Primary DI
04048534002189
Brand
Add Pack Hemo Control DM
Company
EKF-diagnostic GmbH
Model
3040-7201-0099
Catalog number
3040-7201-0099
Device description
For the quantitative determination of hemoglobin in whole blood.
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKRSystem, Hemoglobin, Automated
KHGWhole Blood Hemoglobin Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2
KHGWhole Blood Hemoglobin DeterminationHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048534002189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048534002189040485340021894048534002189

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.

Contacts#

Phone, Email table
PhoneEmail
1-800-531-5535techsupport@ekfdiagnostics.com
+4939203511414support@ekf-diagnostic.de

Regulatory Flags#

DUNS number
330046442
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048534000031Hemo Control Hemoglobin Microcuvette3000-3012-07653000-3012-07652021-05-10
04048534000840Cleaner3000-62323000-62322022-12-21
04048534002165DiaSpect Tm7049-0013-0264900-0012022-10-17
04048534002011EKF Link0760-01010760-01012021-10-15
04048534002035Hemo Control Hemoglobin Microcuvette3000-3012-07653000-3012-07652021-05-10
04048534002028Hemo Control3040-0010-02183040-0010-02182021-05-10
14048534001974DiaSpect Control HBT17049-6211900-5012021-03-12
14048534001981DiaSpect Control HBT27049-6212900-5022021-03-12
14048534001998DiaSpect Control HBT37049-6213900-5032021-03-12
04048534002004DiaSpect Control HBT47049-6214900-5042021-03-12
04048534001977DiaSpect Control HBT17049-6211900-5012021-03-12
04048534001984DiaSpect Control HBT27049-6212900-5022021-03-12
04048534001991DiaSpect Control HBT37049-6213900-5032021-03-12
14048534001967DiaSpect Tm Cuvettes7049-3013-0369900-5002021-03-11
04048534001946DiaSpect Tm7049-0013-0264900-0012021-03-11
24048534001964DiaSpect Tm Cuvettes7049-3013-0369900-5002021-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSGKR2024-07-01
04048534000840CleanerEKF-diagnostic GmbHKHG2022-12-21
04048534000840CleanerEKF-diagnostic GmbHGKR2022-12-21
04048534001540DiaSpect Hemoglobin CuvettesDiaSpect Medical GmbHGKR2022-12-20
17311091118148HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
27311091118077HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
04048534002165DiaSpect TmEKF-diagnostic GmbHGKR2022-10-17
17311091118124HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
27311091118121HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2021-05-10
04048534002035Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHKHG2021-05-10
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
04048534001946DiaSpect TmEKF-diagnostic GmbHGKR2021-03-11
24048534001964DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
17311091118094HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
07311091218278HemoCue® Hb301 AnalyzerHemocue ABGKR2020-09-04
07311091118097HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.GKR2020-04-15
00894472000237B CassetteOPTI MEDICAL SYSTEMS, INC.GKR2019-08-07
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00817869020076Hemoglobin AF ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020083Hemoglobin AC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
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10722355003051hemochroma PLUS Starter KitImmunostics Company, IncGKR2018-12-20