AccessGUDID - DEVICE: MicroFit (00868127000200)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFit
Version or Model: FAS-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROFIT, INC.

Primary DI Number: 00868127000200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103422838 *Terms of Use

Device Description: Multi-component device that connects to a user’s PC computer for measurement, tracking, and reporting of body weight and blood pressure. Device consists of a stand-on body weight scale, non-invasive automatic blood pressure monitor, analog to digital interface unit (CTI), and software (to be installed on the user’s PC computer).

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):	No
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?
16173	Automatic-inflation electronic sphygmomanometer, non-portable	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.	Active	false
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K830003	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9044dc26-18e3-460b-8978-3bafc6254d0a
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: September 26, 2016