Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 00304040004104
• Version / Model: 1126842
• Catalog Number: 1126842
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 432fcd9c-34d2-42c5-9d9a-8a78b683dc37

Device Description

Urispec Urine Dropper Control

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
JJW	URINALYSIS CONTROLS (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30219	Multiple urine analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304040004104	GS1

Premarket Submissions

Submission Number	Supplement Number
K890577	000

Device Sizes

Type	Value	Unit	Text
Total Volume	25	Milliliter
Device Size Text, specify			Box = 2 X 2 X 25 ml

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Can be left at room temperature if used within 30 days
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius