FDA.reportPublic FDA data

HemoCue® Glucose 201 Microcuvettes

Primary DI
07311091107237
Brand
HemoCue® Glucose 201 Microcuvettes
Company
Hemocue AB
Model
110723
Catalog number
110723
Device description
HemoCue Glucose 201 Microcuvettes 2x25 single
Published
2016-05-27
Public version status
Update
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
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
07311091107237PackageGS12In Commercial Distribution
27311091107231PackageGS125In Commercial Distribution
17311091107234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07311091107237073110911072377311091107237
2731109110723127311091107231
1731109110723417311091107234

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care blood glucose monitoring system IVDA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose 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 below 8°C including freezing. Individually packaged microcuvettes can 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
356164426
Device count
1
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

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