AccessGUDID - DEVICE: FreeStyle InsuLinx (00093815715009)

GUDID

Device Identifier (DI) Information

Brand Name: FreeStyle InsuLinx
Version or Model: 71500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71500
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00093815715009
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: FreeStyle InsuLinx Blood Glucose Monitoring System

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
62643	Multiple clinical chemistry analyte monitoring system IVD, home-use	A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
LFR	Glucose dehydrogenase, glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152328	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 40 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a20ecc54-e8e2-4383-8e95-71ca9be4db67
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: August 12, 2016