AccessGUDID - DEVICE: Advocate Control Solutions Low (00894046001585)

GUDID

Device Identifier (DI) Information

Brand Name: Advocate Control Solutions Low
Version or Model: 003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BMB003
Company Name: DIABETIC SUPPLY OF SUNCOAST, INC.

Primary DI Number: 00894046001585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043081723 *Terms of Use

Device Description: Advocate Control Solutions Level 1 Low 4 ml Bottle

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?
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

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
Handling Environment Atmospheric Pressure: between 0 and 85 Percent (%) Relative Humidity
Storage 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: 4213e192-00b3-4793-9359-dd7f83ea964a
Public Version Date: September 02, 2020
Public Version Number: 5
DI Record Publish Date: August 19, 2016