FDA.reportPublic FDA data

Cleaner

Primary DI
14048534002742
Brand
Cleaner
Company
EKF-diagnostic GmbH
Model
3000-6233
Catalog number
3000-6233
Device description
For Cleaning the optical unit of Hemo Control Analyzers.
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
14048534002742PrimaryGS10
04048534002745Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404853400274214048534002742
04048534002745040485340027454048534002745

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
+4939203511414support@ekf-diagnostic.de
1-800-531-5535techsupport@ekfdiagnostics.com

Regulatory Flags#

DUNS number
330046442
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24048534002749Cleaner3000-62353000-62352026-07-31
34048534002456Hemo Control Hemoglobin Microcuvette3000-3112-013000-3112-012026-07-31
44048534002453Hemo Control Hemoglobin Microcuvette3000-3112-023000-3112-022026-07-31
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
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
24048534002749CleanerEKF-diagnostic GmbHGKR2026-07-31
24048534002749CleanerEKF-diagnostic GmbHKHG2026-07-31
34048534002456Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2026-07-31
34048534002456Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
44048534002453Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2026-07-31
44048534002453Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
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 GmbHKHG2022-12-21
04048534000840CleanerEKF-diagnostic GmbHGKR2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHGKR2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHKHG2022-12-21
04048534001540DiaSpect Hemoglobin CuvettesDiaSpect Medical GmbHGKR2022-12-20
17311091118148HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
17311091118124HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2021-05-10
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHKHG2021-05-10
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