AccessGUDID - DEVICE: In Touch Refill Kit (00853553005103)

GUDID

Device Identifier (DI) Information

Brand Name: In Touch Refill Kit
Version or Model: In Touch
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KIT00147
Company Name: LIVONGO HEALTH, INC

Primary DI Number: 00853553005103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829984561 *Terms of Use

Device Description: 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution

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?
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	Active	false
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	Active	false
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Lancet, Blood
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a519b60-696d-4dcf-87e3-68baa903f3ea
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016