Hemo Cue, Inc.

3 devices in the database

  • Model / Serial
    HemoCue Hb 201 DM Analyzers, (USA): Serial Numbers:  0632620050; 0647620080, 0717620162 & 0717620185; 0650620105; 0717620156; 0717620169; 0717620186; 0647620088; 0717620170; 0717620157 & 0717620187;  0647620104, 0650620077, 0650620081, 0650620104, 0706620010, 0706620032, 0706620043, 0706620057, 0706620094, 0709620025 & 0709620031; 0650620066; 0650620112; 0717620152, 0717620153 & 0717620172; 0706620041; 0717620189; 0717620190; 0717620158; 0702620049; 0717620155; 0717620115; 0717620178 & 0717620179; 0717620159; 0717620065 & 0717620174; 0717620165; 0717620181; 0717620167; 0706620019 & 0706620020; 0717620171, 0717620173 & 0717620184; 0717620131; 0717620166, 0717620160, 0717620168 & 0717620180.  HemoCue Hb 201 DM Analyzers, (Europe): Serial Numbers:  0630630060; 0639620042; 0640620003 & 0640620015; 0717620197; 0717620199; 0717620183; 0717620191; 0717620200; 0709620026 & 0709620121; 0709620050, 0709620097, 0717620193, 0717620194, 0717620195 & 0717620196; 0717620163 & 0717620164; 0709620034; 0709620023; 0717620198; 0647620069.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.
  • Product Description
    HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.
  • Model / Serial
    Hb Glucose 201 DM System: (USA): Serial Numbers:  0632720008; 0651720088; 0641720017; 0651720037, 0651720087 & 0651720092; 0707720047; 0639720004; 0641720004, 0641720008,& 0641710015.  Hb Glucose 201 DM System: (Euroope): Serial Numbers:   064172009; 0641720032; 0641720042, 0641720044 & 0644720026 & 0644720050; 0644720006 & 0651720002; 0644720022; 0644720039, 0644720044 & 0651720006.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.
  • Product Description
    HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.
  • Model / Serial
    Lot/batch Number:   US: 1011383*, 1102471 *,1102474*,1102487*,1103200*, 1103201**,1103236*,1103213*,1103216*,1103224*, 1103225*,1103226*,1103238*,1103243**,1103246*, 1103250*,1103496*,1103498*,1104272**,1104273**, 1104288**,1104289**,1104548**,1104549**,1104550**, 1104555**,1104556**,1104558**,1104559**,1103212*, 1103240*,1104557**  * lots have been shipped to customers ** lots are in stock at distributor HemoCue Inc.  Not in US: 1104282, 1105306, 1104530, 1103242, 1103241, 1103244,1103247,1104255,1104258,1103248,1103234, 1104260,1104267,1104274,1104270,1102467,1104277, 1104531,1104532,1104533,1104534,1104535,1103227, 1103228,1103232,1103230,1103233,1104254,1104256, 1103249,1104254,1103245,1104263,1104274,1104286, 1104275,1104283.  The lots that are not for the US market are not affected by the labeling infonnation regarding lithium heparin.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Czech Republic, Denmark, Slovenia, Norway, Sweden, Switzerland, United Kingdom, Finland, Germany, Netherlands, Poland, Romania, and Tanzania.
  • Product Description
    HemoCue Glucose 201 Microcuvettes, || Article Number:110705*,110706,110715**,110716**,110717**,110718**, || 110719** || " No affected lots of this article have been delivered to customers. Still || in stock at distributor HemoCue Inc. || "" Article not available in US || Quantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only and are only to be used with the HemoCue Glucose 201 Analyzer. For professional use only.