P33

Basic Information

• Brand Name: P33
• Primary DI: 00860004081654
• Version / Model: P33-10-MET
• Catalog Number: P33-10-MET
• Company Name: DEUS VULT, LLC
• Labeler DUNS: 086645029
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2021-12-30
• Public Version: 3
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: 3beae78b-03dd-41b9-b694-5813bf89f1f7
• Distribution End Date: 2022-06-30

Device Description

10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	862.3170	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	862.3620	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. 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
Package	00860004081661	GS1	case	4	Not in Commercial Distribution	2022-06-30
Primary	00860004081654	GS1
Unit of Use	00860004081647	GS1

Customer Contacts

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