AccessGUDID - DEVICE: Precision Xtra (00093815715023)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Xtra
Version or Model: 71502
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71502
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00093815715023
Issuing Agency: GS1
Commercial Distribution End Date: April 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: Precision Xtra Blood Glucose & 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):	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
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
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
LFR	Glucose dehydrogenase, glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040814	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: 59ed128b-7c30-4e23-9d48-3d45b6bbe957
Public Version Date: October 18, 2023
Public Version Number: 8
DI Record Publish Date: August 12, 2016