AccessGUDID - DEVICE: Negative DAU Calibrator (B07600010)

GUDID

Device Identifier (DI) Information

Brand Name: Negative DAU Calibrator
Version or Model: 0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0001
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: B07600010
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: negative (drug-free) human urine.

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multiple clinical chemistry analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.

FDA Product Code

[?]

Product Code	Product Code Name
DLJ	Calibrators, Drug Specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020769	000
K023316	000
K031797	000
K032365	000
K032764	000
K033094	000
K090844	000
K102210	000
K113139	000
K113661	000
K120761	000
K120763	000
K133710	000
K141055	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: 609d2368-df10-4935-a134-7c2c1ca19e4e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 19, 2016