Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10884389181959
• Version / Model: MPHUA5OB
• Catalog Number: MPHUA5OB
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-09-16
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 0a2f469d-d4eb-4965-b752-7d55ff768c5b

Device Description

STRIPS,URINE,REAGENT,5OB,100 STRIPS/BT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80884389181958	GS1
Primary	10884389181959	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at 36-86 F (2-30 C) and out of direct sunlight.
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit