AccessGUDID - DEVICE: Bicycle Health (10850013035202)

GUDID

Device Identifier (DI) Information

Brand Name: Bicycle Health
Version or Model: ID-BH9-ADULT-1-AZ25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ID-BH9-ADULT-1-AZ25
Company Name: MEDICAL DISTRIBUTION GROUP INC

Primary DI Number: 10850013035202
Issuing Agency: GS1
Commercial Distribution End Date: July 03, 2045
Device Count: 25
Labeler D-U-N-S® Number*: 064177324 *Terms of Use

Device Description: Bicycle Health 9 Panel Drug Test cup - CLIA Waived AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MET500, MOR/OPI300, OXY100, (NI/CR) Approx. 3mm Strip 25 Tests/Box

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):	No
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
DJG	Enzyme Immunoassay, Opiates
DJR	Enzyme Immunoassay, Methadone
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM	Enzyme Immunoassay, Benzodiazepine
DIS	Enzyme Immunoassay, Barbiturate
DKZ	Enzyme Immunoassay, Amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122809	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: 5d3dab67-35be-41dd-9481-df38d9827e43
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023