AccessGUDID - DEVICE: FreeStyle Libre (00357599000851)

GUDID

Device Identifier (DI) Information

Brand Name: FreeStyle Libre
Version or Model: 71942
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71942
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00357599000851
Issuing Agency: GS1
Commercial Distribution End Date: December 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: FS Libre Sensor Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	Yes
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?
44611	Percutaneous interstitial-fluid glucose monitoring system, electrochemical	An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZE	Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160030	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 39 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd08639e-2008-44e0-8b5b-b8f54658633e
Public Version Date: January 04, 2023
Public Version Number: 6
DI Record Publish Date: June 01, 2018