AccessGUDID - DEVICE: Livongo Replacement Device (00853553005240)

GUDID

Device Identifier (DI) Information

Brand Name: Livongo Replacement Device
Version or Model: Livongo
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KIT00423
Company Name: LIVONGO HEALTH, INC

Primary DI Number: 00853553005240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829984561 *Terms of Use

Device Description: Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)

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:	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?
56684	Home-use/point-of-care glucose analyser IVD, battery-powered	An exclusively battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133584	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 41 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: less than 75 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f56fcc3-1cdf-4c30-bd35-fe7455ba6e98
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016