CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380175589
• Version / Model: UAREADER1
• Catalog Number: UAREADER1
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-09
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: fbce4e77-5f56-4e55-a34f-5de74bcabfe7

Device Description

Urinalysis Analyzer Kit For Urine Contains: 1 - Semi-Atuo Urine Analyzer 6 - Bottles of UA10SGL Strips X1 UAREADER1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1115	1
CEN	Dye-indicator, pH (urinary, non-quantitative)	Clinical Chemistry	862.1550	1
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE	Hematology	864.6550	2
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)	Clinical Chemistry	862.1510	1
JRE	REFRACTOMETER FOR CLINICAL USE	Clinical Chemistry	862.2800	1
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1435	1
JMA	ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)	Clinical Chemistry	862.1095	1
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1785	1
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)	Clinical Chemistry	862.1340	2
LJX	TEST, URINE LEUKOCYTE	Hematology	864.7675	1
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)	Clinical Chemistry	862.1645	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54514	Multiple urine analyte IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.	No	Active
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885380175589	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius