FDA.reportPublic FDA data

DiaSpect Tm Cuvettes

Primary DI
24048534001964
Brand
DiaSpect Tm Cuvettes
Company
EKF-diagnostic GmbH
Model
7049-3013-0369
Catalog number
900-500
Device description
For the quantitative determination of hemoglobin in whole blood.
Published
2021-03-11
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2005200

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2005200

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24048534001964PackageGS110In Commercial Distribution
14048534001967PrimaryGS10
04048534001953Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2404853400196424048534001964
1404853400196714048534001967
04048534001953040485340019534048534001953

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4939203511414support@ekf-diagnostic.de

Regulatory Flags#

DUNS number
330046442
Device count
500
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
false
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
04048534000031Hemo Control Hemoglobin Microcuvette3000-3012-07653000-3012-07652021-05-10
04048534000840Cleaner3000-62323000-62322022-12-21
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

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 GmbHGKR2022-12-21
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 GmbHGKR2021-05-10
04048534002035Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHGKR2021-05-10
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
04048534001946DiaSpect TmEKF-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
10722355003020hemochroma PLUS MicrocuvettesImmunostics Company, IncGKR2018-12-20
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerImmunostics Company, IncGKR2018-12-20
10722355003051hemochroma PLUS Starter KitImmunostics Company, IncGKR2018-12-20
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSGKR2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSGKR2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSGKR2018-09-21
10612479234090McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
10612479234120McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
10612479234144McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
17311091117318HemoCue® Hb 201 MicrocuvettesHemocue ABGKR2018-05-25