FDA.reportPublic FDA data

HemoCue® Glucose 201 Microcuvettes

Primary DI
17311091107067
Brand
HemoCue® Glucose 201 Microcuvettes
Company
Hemocue AB
Model
110706
Catalog number
110706
Device description
HemoCue Glucose 201 Microcuvettes 4x25 vial
Published
2016-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020935000HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706Hemocue, Inc.2002-04-03CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07311091107060PackageGS14In Commercial Distribution
17311091107067PrimaryGS10
27311091107064Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07311091107060073110911070607311091107060
1731109110706717311091107067
2731109110706427311091107064

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store unopened vials below 8°C incl freezing. Opened vial are stable for 30 days at 2-8°C. Vial can also be stored at 15-30°C for up to 3 days. The reagent is moisture and temperature sensitive.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature35 Degrees Fahrenheit46 Degrees Fahrenheit

Regulatory Flags#

DUNS number
356164426
Device count
25
Lot or batch
true
Expiration date on label
true

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
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
17311091106084HemoCue® Urine Albumin Microcuvettes1106081106082019-04-25

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