DPI

Basic Information

• Brand Name: DPI
• Primary DI: 00810042680340
• Version / Model: 18002998
• Catalog Number: 18002998
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• Labeler DUNS: 028007698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-20
• Public Version: 1
• Public Version Date: 2020-10-28
• Public Version Status: New
• Public Device Record Key: dcc9b4db-afcb-4dcb-ae8a-f86ba0d8eb90

Device Description

H-Trol 1 5ml

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DIF	Drug Mixture Control Materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55461	Multiple drugs of abuse IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042680340	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius