AccessGUDID - DEVICE: Preferred Med Supply (00860004081609)

GUDID

Device Identifier (DI) Information

Brand Name: Preferred Med Supply
Version or Model: PF12P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PF12P
Company Name: DEUS VULT, LLC

Primary DI Number: 00860004081609
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 086645029 *Terms of Use

Device Description: Multi-panel Drug Test Cup

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBF	Test, Propoxyphene, Over The Counter
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter
NGI	Test, Morphine, Over The Counter
NGL	Test, Opiates, Over The Counter
PTG	Test, Methadone, Over The Counter
NGG	Test, Methamphetamine, Over The Counter
NGM	Test, Phencyclidine (Pcp), Over The Counter
PTH	Test, Barbiturate, Over The Counter
QAW	Test, Tricyclic Antidepressants, Over The Counter
NFT	Test, Amphetamine, Over The Counter
NFW	Test, Cannabinoid, Over The Counter
NFV	Test, Benzodiazepine, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182654	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ad277b5-1210-4531-8f4c-bd6f5162fedf
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: August 11, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00860004081616	3	00860004081609	2021-12-31	Not in Commercial Distribution	Box
00860004081623	25	00860004081609	2021-12-31	Not in Commercial Distribution	Box
00860004081630	4	00860004081623	2021-12-31	Not in Commercial Distribution	Case