AccessGUDID - DEVICE: P33 (00860004081654)

GUDID

Device Identifier (DI) Information

Brand Name: P33
Version or Model: P33-10-MET
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P33-10-MET
Company Name: DEUS VULT, LLC

Primary DI Number: 00860004081654
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2022
Device Count: 25
Labeler D-U-N-S® Number*: 086645029 *Terms of Use

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

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
NFT	Test, Amphetamine, Over The Counter
NFV	Test, Benzodiazepine, Over The Counter
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter
NGG	Test, Methamphetamine, Over The Counter
PTG	Test, Methadone, Over The Counter
NGL	Test, Opiates, Over The Counter
NFW	Test, Cannabinoid, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 3beae78b-03dd-41b9-b694-5813bf89f1f7
Public Version Date: January 08, 2024
Public Version Number: 3
DI Record Publish Date: December 30, 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
00860004081661	4	00860004081654	2022-06-30	Not in Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00860004081647 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-876-6355
Email: cs@PreferredMedSupply.com

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