FDA.reportPublic FDA data

HemoCue® Hb 201 Microcuvettes

Primary DI
07311091117311
Brand
HemoCue® Hb 201 Microcuvettes
Company
Hemocue AB
Model
111731
Catalog number
111731
Device description
HemoCue Hb 201 Microcuvettes 4x50 vial
Published
2018-05-25
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

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
K032203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032203000HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704Hemocue, Inc.2003-08-25GKR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07311091117311PackageGS14In Commercial Distribution
17311091117318PrimaryGS10
27311091117315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07311091117311073110911173117311091117311
1731109111731817311091117318
2731109111731527311091117315

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, Specify00Store in a dry place
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
356164426
Device count
50
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
17311091130034HemoCue® WBC Microcuvettes1130031130032016-05-31
07311091230010HemoCue® WBC Analyzer1230011230012016-05-31
17311091118148HemoCue® Hb 301 Microcuvettes1118141118142022-10-28
27311091118077HemoCue® Hb 301 Microcuvettes1118141118142022-10-28
17311091118094HemoCue® Hb 301 Microcuvettes1118091118092020-09-04
17311091118124HemoCue® Hb 301 Microcuvettes1118121118122022-08-30
17311091107050HemoCue® Glucose 201 Microcuvettes1107051107052016-05-31
17311091107067HemoCue® Glucose 201 Microcuvettes1107061107062016-05-31
17311091107234HemoCue® Glucose 201 Microcuvettes1107231107232016-05-27
07311091207067HemoCue® Glucose 201 Analyzer1207061207062016-05-31
07311091207074HemoCue® Glucose 201 Analyzer1207071207072016-05-31
07311091214225HemoCue® Glucose 201 DM Analyzer1214221214222016-05-31
07311091214447HemoCue® Glucose 201 DM Analyzer1214441214442016-05-31
17311091218046HemoCue® Hb301 Analyzer1218041218042016-05-31
27311091118121HemoCue® Hb 301 Microcuvettes1118121118122022-08-30
07311091391681HemoCue® 801 Connect1391681391682019-04-25
17311091118070HemoCue® Hb 301 Microcuvettes1118071118072016-12-01
07311091218278HemoCue® Hb301 Analyzer1218271218272020-09-04
07311091118097HemoCue® Hb 301 Microcuvettes1118091118092020-09-04
07311091206237HemoCue® Albumin 201 Analyzer1206231206232019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14048534002742CleanerEKF-diagnostic GmbHGKR2026-07-31
24048534002749CleanerEKF-diagnostic GmbHGKR2026-07-31
34048534002456Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
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 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
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