AccessGUDID - DEVICE: FreeStyle Precision Pro (00093815714118)

GUDID

Device Identifier (DI) Information

Brand Name: FreeStyle Precision Pro
Version or Model: 71411-70
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71411-70
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00093815714118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: FreeStyle Precision Pro Blood Glucose and ?-Ketone 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:	No
Prescription Use (Rx):	No
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?
62644	Multiple clinical chemistry analyte monitoring system IVD, point-of-care	A collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFR	Glucose dehydrogenase, glucose
JQP	CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132511	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 -4 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70e37c0b-e2ad-4921-9604-c3e37b4b4dfa
Public Version Date: May 14, 2024
Public Version Number: 6
DI Record Publish Date: August 12, 2016