AccessGUDID - DEVICE: HemoCue® WBC Analyzer (07311091230010)

GUDID

Device Identifier (DI) Information

Brand Name: HemoCue® WBC Analyzer
Version or Model: 123001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 123001
Company Name: Hemocue AB

Primary DI Number: 07311091230010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 356164426 *Terms of Use

Device Description: HemoCue WBC Analyzer x10^9 /L

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Haematological cell analyser IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

GMDN Preferred Term Name

GMDN Definition

Haematological cell analyser IVD, semi-automated

A mains electricity (AC-powered) laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

FDA Product Code

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Product Code	Product Code Name
GKL	Counter, Cell, Automated (Particle Counter)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071652	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Storage in <90 % non-condensing humidity
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd415ab7-713e-4045-a943-39ca31281462
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 31, 2016