AccessGUDID - DEVICE: Precision Xtra (00093815998778)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Xtra
Version or Model: 99877
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99877
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00093815998778
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: Precision Xtra Blood Glucose 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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Glucose/ketone monitoring system IVD, home-use	A collection of devices including a portable, battery-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 glucose and ketones in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Glucose/ketone monitoring system IVD, point-of-care	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose and ketones in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

GMDN Preferred Term Name

GMDN Definition

Glucose/ketone monitoring system IVD, home-use

A collection of devices including a portable, battery-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 glucose and ketones in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Glucose/ketone monitoring system IVD, point-of-care

A collection of devices including a portable, battery-powered, semi-automated or automated instrument (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose and ketones in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051213	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

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Storage and Handling
Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a30d5c47-7903-4671-95b0-fceb1e4bf472
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 22, 2016