AccessGUDID - DEVICE: Pointe Hydrocodone 300 Level 1 Control (225 ng/mL) (00811727016836)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Hydrocodone 300 Level 1 Control (225 ng/mL)
Version or Model: 60-HY0794-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-HY0794-5
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727016836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Hydrocodone 300 Level 1 Control (225 ng/mL) 1 x 5 mL The Pointe Hydrocodone 300 Controls are for use as assayed quality control materials to monitor the precision of the PointeHydrocodone 300 Reagent Set (Ref# 60-HY0780-100/60-HY0780-1L) 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?
55461	Multiple drugs of abuse 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 one or multiple drugs of abuse 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 [?]
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: a8b7cca2-7764-4293-a1fc-4c7e3904d0e5
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020