AccessGUDID - DEVICE: Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count (00894046001875)

GUDID

Device Identifier (DI) Information

Brand Name: Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count
Version or Model: BMB002-35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BMB002-35
Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.

Primary DI Number: 00894046001875
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 35
Labeler D-U-N-S® Number*: 043081723 *Terms of Use

Device Description: Advocate Redi-Code+ Test Strips for accurate monitoring of blood glucose levels 35 Count

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):	No
Over the Counter (OTC):	Yes
Kit:	No
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?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Atmospheric Pressure: between 0 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 39.2 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 40 Degrees Celsius
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3961b638-8a66-48f3-818a-97ed7553a3da
Public Version Date: November 25, 2020
Public Version Number: 5
DI Record Publish Date: August 19, 2016