AccessGUDID - DEVICE: FreeStyle Precision Pro (00093815712886)

GUDID

Device Identifier (DI) Information

Brand Name: FreeStyle Precision Pro
Version or Model: 71288
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71288
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00093815712886
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: FreeStyle Precision Pro Blood ß-Ketone Test Strips

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:	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?
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 39 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4478ff9c-b178-45bb-ab61-81f3ada15082
Public Version Date: December 11, 2019
Public Version Number: 7
DI Record Publish Date: August 12, 2016