AccessGUDID - DEVICE: Pointe Cannabinoids (THC) Calibrator (100 ng/mL) (00811727017345)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Cannabinoids (THC) Calibrator (100 ng/mL)
Version or Model: 60-TH0154-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-TH0154-5
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727017345
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Cannabinoids (THC) Calibrator (100 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.

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?
55551	Cannabinoid/cannabinoid metabolite IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DLJ	Calibrators, Drug Specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110239	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: 6a7ebf5e-3f71-4667-951b-ea96608fe12e
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: September 25, 2020