AccessGUDID - DEVICE: Pointe Glucose Reagent (00811727016157)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Glucose Reagent
Version or Model: 16-G7517-528
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16-G7517-528
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727016157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Glucose Reagent packaged for use on the Mindray BA800. 8 x 66ml. For the in vitro quantitative measurement of glucose in serum.

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?
53301	Glucose IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFR	Hexokinase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961282	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: 0b98614c-846a-448b-9b8c-a5112117d652
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: January 30, 2021