FDA.reportPublic FDA data

Hemo Control

Primary DI
04048534002028
Brand
Hemo Control
Company
EKF-diagnostic GmbH
Model
3040-0010-0218
Catalog number
3040-0010-0218
Device description
For the quantitative determination of hemoglobin in whole blood.
Published
2021-05-10
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
04048534002028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048534002028040485340020284048534002028

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
330046442
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048534000840Cleaner3000-62323000-62322022-12-21
04048534000031Hemo Control Hemoglobin Microcuvette3000-3012-07653000-3012-07652021-05-10
04048534002189Add Pack Hemo Control DM3040-7201-00993040-7201-00992022-12-21
04048534002165DiaSpect Tm7049-0013-0264900-0012022-10-17
04048534002011EKF Link0760-01010760-01012021-10-15
04048534002035Hemo Control Hemoglobin Microcuvette3000-3012-07653000-3012-07652021-05-10
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
05700693930978ABL90 FLEXRadiometer Medical ApSGKR2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSGKR2026-07-09
05700699446572SP90Radiometer Medical ApSGKR2026-07-09
05700699447579SP90Radiometer Medical ApSGKR2026-07-09
05700699461056SC90Radiometer Medical ApSGKR2026-07-09
05700699461087SC90Radiometer Medical ApSGKR2026-07-09
05700699461094SC90Radiometer Medical ApSGKR2026-07-09
05700699461100SC90Radiometer Medical ApSGKR2026-07-09
05700699461131SC90Radiometer Medical ApSGKR2026-07-09
05700699461605SC90Radiometer Medical ApSGKR2026-07-09
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSGKR2024-07-01
04048534000840CleanerEKF-diagnostic GmbHGKR2022-12-21
04048534000840CleanerEKF-diagnostic GmbHKHG2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHKHG2022-12-21
04048534002189Add Pack Hemo Control DMEKF-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 GmbHKHG2021-05-10
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
17311091118094HemoCue® 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
10722355003020hemochroma PLUS MicrocuvettesImmunostics Company, IncGKR2018-12-20
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerImmunostics Company, IncGKR2018-12-20