HemoCue® Plasma/Low Hb Microcuvettes 110302

GUDID 07311091103024

HemoCue Plasma/Low Hb Microcuvettes 4x25 vial

Hemocue AB

Haemoglobin analyser IVD, point-of-care Haemoglobin analyser IVD, point-of-care
Primary Device ID07311091103024
NIH Device Record Key9669ec20-4946-4ecf-8938-b78cb9b4e1ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoCue® Plasma/Low Hb Microcuvettes
Version Model Number110302
Catalog Number110302
Company DUNS356164426
Company NameHemocue AB
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not refrigerate
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107311091103024 [Package]
Contains: 17311091103021
Package: package [4 Units]
In Commercial Distribution
GS117311091103021 [Primary]
GS127311091103028 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKRSystem, Hemoglobin, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-27

Devices Manufactured by Hemocue AB

27311091118077 - HemoCue® Hb 301 Microcuvettes2022-11-07 HemoCue Hb 301 Microcuvettes 4x75 vial
27311091118121 - HemoCue® Hb 301 Microcuvettes2022-09-07 HemoCue Hb 301 Microcuvettes 4x50 vial
07311091218278 - HemoCue® Hb301 Analyzer2020-09-14 HemoCue Hb301 Analyzer g/dL
07311091118097 - HemoCue® Hb 301 Microcuvettes2020-09-14 HemoCue Hb 301 Microcuvettes 4x50 vial
07311091391681 - HemoCue® 801 Connect2019-07-02 HemoCue® 801 Connect
07311091206237 - HemoCue® Albumin 201 Analyzer2019-05-03 HemoCue Albumin 201 Analyzer mg/L
17311091106084 - HemoCue® Urine Albumin Microcuvettes2019-05-03 HemoCue Urine Albumin Microcuvettes 2x25 single
17311091119022 - HemoCue® Hb 801 Microcuvettes2019-03-11 HemoCue Hb 801 Microcuvettes 4x50 vial

Trademark Results [HemoCue]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMOCUE
HEMOCUE
77756134 3912761 Live/Registered
HemoCue AB
2009-06-10
HEMOCUE
HEMOCUE
73352049 1222479 Dead/Cancelled
Aktiebolaget Leo
1982-02-26

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