AccessGUDID - DEVICE: Cocaine Metabolite DAU Control, Level 2 Control (B07600380)

GUDID

Device Identifier (DI) Information

Brand Name: Cocaine Metabolite DAU Control, Level 2 Control
Version or Model: 0038
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0038
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: B07600380
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 840839190 *Terms of Use

Device Description: 5mL/bottle. Concentration: 375 ng/mL of Benzoylecgonine.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
55569	Cocaine/cocaine metabolite 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 cocaine and/or cocaine metabolites in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020769	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e9e1690-1969-4320-b3ce-6d47cf4f6442
Public Version Date: August 24, 2018
Public Version Number: 4
DI Record Publish Date: July 05, 2016