Diabetic Specialty Solutions

Basic Information

• Brand Name: Diabetic Specialty Solutions
• Primary DI: 00025715669908
• Version / Model: 66990
• Company Name: APOTHECARY PRODUCTS, LLC
• Labeler DUNS: 092312735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 1
• Public Version Date: 2020-09-18
• Public Version Status: New
• Public Device Record Key: 6891111b-1a4a-4b3d-aaa9-080a62c294dd

Device Description

TEMP PH TEST PAPER PPK 6/72

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	862.1550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63695	Urine test strip colour chart IVD	A device in the form of a printed chart designed for the qualitative and semi-quantitative assessment of urine analyte (e.g., ketones, glucose, nitrites, leukocytes) concentration/pH by visually comparing urine test strip colour with a standard scale of colour variations that correlate with urine analyte concentration/pH. It is typically used to screen paediatric urine by clinicians in a healthcare facility or by laypersons in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20025715669902	GS1	bag	6	In Commercial Distribution
Primary	00025715669908	GS1
Package	10025715669905	GS1	case	12	In Commercial Distribution
Unit of Use	40025715232858	GS1

Customer Contacts

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