AccessGUDID - DEVICE: CARDINAL HEALTH (10885380175596)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: UAREADER2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UAREADER2
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380175596
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Semi-Auto Urine Analyzer For Urine Light Weight Compact Design Full Duplex Communication Interface Internal/external Printer Interface Easy Cleaning Display in 8 Languages UAREADER2

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57860	Urine analyser IVD, laboratory, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KQO	AUTOMATED URINALYSIS SYSTEM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35a12666-031b-4dc7-a550-32f830f9c08d
Public Version Date: July 15, 2020
Public Version Number: 1
DI Record Publish Date: July 07, 2020